{"id":3023,"date":"2025-04-07T06:07:01","date_gmt":"2025-04-07T06:07:01","guid":{"rendered":"https:\/\/hanheng.easiwin.com\/?p=3023"},"modified":"2025-04-07T06:07:03","modified_gmt":"2025-04-07T06:07:03","slug":"medical-swabs-brushes20250429","status":"publish","type":"post","link":"https:\/\/hanheng-medical.com\/ko\/blog\/medical-swabs-brushes20250429\/","title":{"rendered":"2025\ub144 \uc758\ub8cc\uc6a9 \uba74\ubd09 \ubc0f \ube0c\ub7ec\uc2dc\uc5d0 \uc601\ud5a5\uc744 \ubbf8\uce58\ub294 \uaddc\uc81c \ubcc0\uacbd \uc0ac\ud56d: \ub3c4\ub9e4 \uad6c\ub9e4\uc790 \ubc0f \uc720\ud1b5\uc5c5\uccb4\uac00 \uc54c\uc544\uc57c \ud560 \uc0ac\ud56d"},"content":{"rendered":"<ol class=\"wp-block-list\">\n<li>\uc18c\uac1c: \uc758\ub8cc\uc6a9 \uba74\ubd09 \ubc0f \ube0c\ub7ec\uc2dc\uc758 \uaddc\uc81c \ubcc0\ud654\uc758 \uc911\uc694\uc131 \uc774\ud574<\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">\uc758\ub8cc \uc18c\ubaa8\ud488\uc5d0 \ub300\ud55c \uae00\ub85c\ubc8c \ud658\uacbd\uc740 2025\ub144\uc5d0 \uac00\uae4c\uc6cc\uc9d0\uc5d0 \ub530\ub77c \uc0c1\ub2f9\ud55c \ubcc0\ud654\ub97c \uacaa\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uac00\uc7a5 \ud070 \uc601\ud5a5\uc744 \ubc1b\ub294 \uc81c\ud488 \ubc94\uc8fc \uc911\uc5d0\ub294 \ud45c\ubcf8 \uc218\uc9d1, \uc9c4\ub2e8 \ubc0f \uc9c8\ubcd1 \uc120\ubcc4\uc5d0 \uc911\uc694\ud55c \uc5ed\ud560\uc744 \ud558\ub294 \uc758\ub8cc\uc6a9 \uba74\ubd09\uacfc \ube0c\ub7ec\uc2dc\uac00 \uc788\uc2b5\ub2c8\ub2e4. \uc758\ub8cc \uae30\uae30 \uc548\uc804, \uba78\uade0\uc131 \ubc0f \ucd94\uc801\uc131\uc5d0 \ub300\ud55c \uc870\uc0ac\uac00 \uc99d\uac00\ud568\uc5d0 \ub530\ub77c \uc804 \uc138\uacc4 \uaddc\uc81c \uae30\uad00\uc774 \uc694\uad6c \uc0ac\ud56d\uc744 \uc5c5\ub370\uc774\ud2b8\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\uc720\ud1b5\uc5c5\uccb4, \ubcd1\uc6d0 \uc870\ub2ec \uad00\ub9ac\uc790, OEM \ud30c\ud2b8\ub108 \ubc0f \uc804\uc790 \uc0c1\uac70\ub798 B2B \uc758\ub8cc \uacf5\uae09\uc5c5\uccb4\ub97c \ud3ec\ud568\ud55c B2B \uc774\ud574 \uad00\uacc4\uc790\uc5d0\uac8c \uc774\ub7ec\ud55c \ubcc0\ud654\ub294 \uacfc\uc81c\uc640 \uae30\ud68c\ub97c \ubaa8\ub450 \uc81c\uc2dc\ud569\ub2c8\ub2e4. \uaddc\uc81c \ubcc0\ud654\ub97c \uc55e\uc11c \ub098\uac00\ub294 \uac83\uc740 \ub2e8\uc21c\ud55c \uaddc\uc815 \uc900\uc218\uac00 \uc544\ub2c8\ub77c \uc81c\ud488\uc758 \uc2dc\uc7a5\uc131\uc744 \uc720\uc9c0\ud558\uace0, \uc704\ud5d8\uc744 \uc904\uc774\uace0, \uacf5\uae09\ub9dd\uc758 \uc5f0\uc18d\uc131\uc744 \ubcf4\uc7a5\ud558\ub294 \uac83\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\uc758\ub8cc\uc6a9 \uba74\ubd09\uacfc \ube0c\ub7ec\uc2dc\uac00 \uaddc\uc81c \ub300\uc0c1\uc774 \ub418\ub294 \uc774\uc720\ub294 \ubb34\uc5c7\uc785\ub2c8\uae4c?<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\ub9ce\uc740 \uad6d\uac00\uc5d0\uc11c \ud074\ub798\uc2a4 I \ub610\ub294 II \uc758\ub8cc \uae30\uae30\uc774\ubbc0\ub85c \uc5c4\uaca9\ud55c \uc720\ud6a8\uc131 \uac80\uc0ac\uac00 \ud544\uc694\ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\ubd80\uc801\uc808\ud55c \uc0d8\ud50c\ub9c1 \ub3c4\uad6c\ub294 \uc9c4\ub2e8 \uc815\ud655\uc131\uc744 \uc704\ud0dc\ub86d\uac8c \ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\uc774\ub7ec\ud55c \ud488\ubaa9\uc740 \uc810\ub9c9 \ubc0f \ub0b4\ubd80 \uc870\uc9c1\uacfc \uc9c1\uc811 \uc811\ucd09\ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li>COVID-19\ub294 \uc548\uc804\ud558\uace0 \uba78\uade0\ub418\uba70 \uc2e0\ub8b0\ud560 \uc218 \uc788\ub294 \uc0d8\ud50c\ub9c1 \uc7a5\uce58\uc758 \uc911\uc694\uc131\uc744 \uac15\uc870\ud588\uc2b5\ub2c8\ub2e4.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\uc774 \ube14\ub85c\uadf8\uc5d0\uc11c \ub2e4\ub8f0 \ub0b4\uc6a9:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>2025\ub144 \uba74\ubd09 \ubc0f \ube0c\ub7ec\uc2dc\uc5d0 \uc601\ud5a5\uc744 \ubbf8\uce58\ub294 \uc8fc\uc694 \uaddc\uc81c \ubcc0\uacbd \uc0ac\ud56d.<\/li>\n\n\n\n<li>\ub3c4\ub9e4 \uad6c\ub9e4\uc790, \uacf5\uae09\uc5c5\uccb4 \ubc0f OEM \uc81c\uc870\uc5c5\uccb4\uc5d0 \ubbf8\uce58\ub294 \uc601\ud5a5.<\/li>\n\n\n\n<li>\uaddc\uc815\uc744 \uc900\uc218\ud558\uace0 \uc62c\ubc14\ub978 \uc778\uc99d \uacf5\uae09\uc5c5\uccb4\ub97c \uc120\ud0dd\ud558\ub294 \ubc29\ubc95.<\/li>\n\n\n\n<li>\uc911\uad6d\uc758 \uc8fc\uc694 \uc81c\uc870\uc5c5\uccb4\uc778 Jiangsu Hanheng Medical Technology Co., Ltd.\uc5d0 \ub300\ud55c \uc2a4\ud3ec\ud2b8\ub77c\uc774\ud2b8.<\/li>\n<\/ul>\n\n\n\n<ol start=\"2\" class=\"wp-block-list\">\n<li>2025\ub144 \uae00\ub85c\ubc8c \uaddc\uc81c \ud658\uacbd: \ubbf8\uad6d, EU \ubc0f \uc544\uc2dc\uc544\uc758 \uc8fc\uc694 \ubcc0\uacbd \uc0ac\ud56d<\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">\uc9c4\ud654\ud558\ub294 \uaddc\uc81c \ud658\uacbd\uc744 \ud0d0\uc0c9\ud558\uae30 \uc704\ud574 \ub3c4\ub9e4 \uad6c\ub9e4\uc790 \ubc0f \uae00\ub85c\ubc8c \uc720\ud1b5\uc5c5\uccb4\ub294 \uc8fc\uc694 \uaddc\uc81c \uae30\uad00\uc5d0\uc11c \uad6c\ud604\ud558\ub294 \uc5c5\ub370\uc774\ud2b8\ub97c \uc774\ud574\ud574\uc57c \ud569\ub2c8\ub2e4. \uac00\uc7a5 \uc911\uc694\ud55c \uc608\uc815\ub41c \ubcc0\uacbd \uc0ac\ud56d\uc5d0 \ub300\ud55c \ubd84\uc11d\uc740 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\ubbf8\uad6d: \ud074\ub798\uc2a4 I \ubc0f II \uc7a5\uce58\uc5d0 \ub300\ud55c FDA \uc5c5\ub370\uc774\ud2b8<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>UDI (<a href=\"https:\/\/en.wikipedia.org\/wiki\/Unique_Device_Identification\" target=\"_blank\" rel=\"noopener\">\uace0\uc720 \uc7a5\uce58 \uc2dd\ubcc4\uc790<\/a>) \uc758\ubb34 \ud655\ub300: \uba74\ubd09 \ubc0f \ube0c\ub7ec\uc2dc\ub97c \ud3ec\ud568\ud55c \ubaa8\ub4e0 \ud074\ub798\uc2a4 I \uc7a5\uce58\ub294 2025\ub144 \uc911\ubc18\uae4c\uc9c0 UDI \ub77c\ubca8\ub9c1\uc774 \ud544\uc694\ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\uc5c5\ub370\uc774\ud2b8\ub41c \uc0dd\uccb4 \uc801\ud569\uc131 \ud14c\uc2a4\ud2b8 \uc694\uad6c \uc0ac\ud56d: \uc804\uccb4 \uc138\ud3ec \ub3c5\uc131, \uac10\uc791\uc131 \ubc0f \uc790\uadf9\uc131 \ud14c\uc2a4\ud2b8\ub97c \ud3ec\ud568\ud55c ISO 10993-1 \ud45c\uc900\uc5d0 \ub300\ud55c \uac15\uc870.<\/li>\n\n\n\n<li>\uc0c8\ub85c\uc6b4 eSTAR \uc81c\ucd9c \ud504\ub85c\uc138\uc2a4: FDA\ub294 eSTAR \ud615\uc2dd\uc744 \uc0ac\uc6a9\ud558\uc5ec 510(k) \ubc0f \uc0ac\uc804 \uc2dc\uc7a5 \uc54c\ub9bc\uc5d0 \ub300\ud55c \uc804\uc790 \uc81c\ucd9c\uc744 \uc758\ubb34\ud654\ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\uc720\ub7fd \uc5f0\ud569: MDR(\uc758\ub8cc \uae30\uae30 \uaddc\uc815) \ucd5c\uc885 \uaddc\uc815 \uc900\uc218 \ub9c8\uac10\uc77c<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\ub808\uac70\uc2dc \uc7a5\uce58 \ub354 \uc774\uc0c1 \uba74\uc81c\ub418\uc9c0 \uc54a\uc74c: \ubaa8\ub4e0 \ud074\ub798\uc2a4 I \uc758\ub8cc \uc18c\ubaa8\ud488\uc740 2025\ub144 3\ubd84\uae30\uae4c\uc9c0 \uc644\uc804\ud788 MDR\uc744 \uc900\uc218\ud574\uc57c \ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li>PMS(\uc2dc\ud310 \ud6c4 \uac10\uc2dc) \uc694\uad6c \uc0ac\ud56d: \uc720\ud1b5\uc5c5\uccb4\ub294 \uc9c0\uc18d\uc801\uc778 \uc131\ub2a5 \ubaa8\ub2c8\ud130\ub9c1\uc5d0 \ucc38\uc5ec\ud574\uc57c \ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li>EUDAMED \ub4f1\ub85d: \ubaa8\ub4e0 \uc81c\uc870\uc5c5\uccb4 \ubc0f \uc218\uc785\uc5c5\uccb4\ub294 \uc81c\ud488\uc774 EU \ub370\uc774\ud130\ubca0\uc774\uc2a4\uc5d0 \ub4f1\ub85d\ub418\uc5b4 \uc788\ub294\uc9c0 \ud655\uc778\ud574\uc57c \ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\uc544\uc2dc\uc544 \ud0dc\ud3c9\uc591: \ud604\uc9c0\ud654\ub41c \uaddc\uc81c \uac1c\uc120<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\uad6d\uac00<\/th><th>\uaddc\uc815<\/th><th>\uc8fc\uc694 2025\ub144 \ubcc0\uacbd \uc0ac\ud56d<\/th><\/tr><\/thead><tbody><tr><td>\uc911\uad6d<\/td><td>NMPA<\/td><td>\uac15\ud654\ub41c GMP \uac10\uc0ac \ubc0f \ubb34\uc791\uc704 \uac80\uc0ac \uc99d\uac00<\/td><\/tr><tr><td>\uc77c\ubcf8<\/td><td>PMDA<\/td><td>\ud074\ub798\uc2a4 I \uc7a5\uce58\uc5d0 \ub300\ud55c \uc0c8\ub85c\uc6b4 \uc804\uc790 \uc81c\ucd9c \uc2dc\uc2a4\ud15c<\/td><\/tr><tr><td>\uc778\ub3c4<\/td><td>CDSCO<\/td><td>\uc218\uc785\ud488\uc5d0 \ub300\ud55c \ud544\uc218 \uba78\uade0 \uc720\ud6a8\uc131 \uac80\uc0ac \ubcf4\uace0\uc11c<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\uaddc\uc815 \uc900\uc218\ub97c \uc704\ud55c \uc758\ubbf8:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>OEM \ubc0f \uac1c\uc778 \ub77c\ubca8 \ud310\ub9e4\uc790\ub294 \uc81c\uc870\uc5c5\uccb4\uc758 \ubaa8\ub4e0 \ubb38\uc11c\ub97c \ud655\uc778\ud574\uc57c \ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\uc720\ud1b5\uc5c5\uccb4\ub294 \ucd94\uc801\uc131 \ubc0f \uc720\ud6a8\uc131 \uac80\uc0ac\ub41c \uba78\uade0\uc744 \ubcf4\uc7a5\ud574\uc57c \ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li>B2B \uc804\uc790 \uc0c1\uac70\ub798 \ud310\ub9e4\uc790\ub294 \uaddc\uc81c \uacf5\uac1c\uc640 \ud568\uaed8 \uc81c\ud488 \ubaa9\ub85d\uc744 \uc5c5\ub370\uc774\ud2b8\ud574\uc57c \ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n\n\n\n<figure class=\"wp-block-gallery has-nested-images columns-default is-cropped wp-block-gallery-1 is-layout-flex wp-block-gallery-is-layout-flex\">\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" data-id=\"2982\" src=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Nylon-Flocked-Endocervical-Swab-with-Stopper-HPV-DNA-tests-for-cervical-cancer-screening-A-09-2.jpg\" alt=\"\" class=\"wp-image-2982\" title=\"\" srcset=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Nylon-Flocked-Endocervical-Swab-with-Stopper-HPV-DNA-tests-for-cervical-cancer-screening-A-09-2.jpg 800w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Nylon-Flocked-Endocervical-Swab-with-Stopper-HPV-DNA-tests-for-cervical-cancer-screening-A-09-2-300x300.jpg 300w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Nylon-Flocked-Endocervical-Swab-with-Stopper-HPV-DNA-tests-for-cervical-cancer-screening-A-09-2-150x150.jpg 150w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Nylon-Flocked-Endocervical-Swab-with-Stopper-HPV-DNA-tests-for-cervical-cancer-screening-A-09-2-768x768.jpg 768w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" data-id=\"2972\" src=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Non-Woven-SwabEquipement-and-Electronic-Devices-Maintenance-Cleaning-G-040-2.jpg\" alt=\"\" class=\"wp-image-2972\" title=\"\" srcset=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Non-Woven-SwabEquipement-and-Electronic-Devices-Maintenance-Cleaning-G-040-2.jpg 800w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Non-Woven-SwabEquipement-and-Electronic-Devices-Maintenance-Cleaning-G-040-2-300x300.jpg 300w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Non-Woven-SwabEquipement-and-Electronic-Devices-Maintenance-Cleaning-G-040-2-150x150.jpg 150w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Non-Woven-SwabEquipement-and-Electronic-Devices-Maintenance-Cleaning-G-040-2-768x768.jpg 768w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" data-id=\"2969\" src=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Dry-Transport-SwabFlocked-Oropharyngeal-Swab-OP-Specimen-Collection-Self-Sampling-and-Transportation-C-02-3.jpg\" alt=\"\" class=\"wp-image-2969\" title=\"\" srcset=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Dry-Transport-SwabFlocked-Oropharyngeal-Swab-OP-Specimen-Collection-Self-Sampling-and-Transportation-C-02-3.jpg 800w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Dry-Transport-SwabFlocked-Oropharyngeal-Swab-OP-Specimen-Collection-Self-Sampling-and-Transportation-C-02-3-300x300.jpg 300w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Dry-Transport-SwabFlocked-Oropharyngeal-Swab-OP-Specimen-Collection-Self-Sampling-and-Transportation-C-02-3-150x150.jpg 150w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Dry-Transport-SwabFlocked-Oropharyngeal-Swab-OP-Specimen-Collection-Self-Sampling-and-Transportation-C-02-3-768x768.jpg 768w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/figure>\n<\/figure>\n\n\n\n<ol start=\"3\" class=\"wp-block-list\">\n<li>\uaddc\uc81c \uc5c5\ub370\uc774\ud2b8\uac00 \ub3c4\ub9e4 \uad6c\ub9e4\uc790, \uc720\ud1b5\uc5c5\uccb4 \ubc0f OEM \ud30c\ud2b8\ub108\uc5d0\uac8c \ubbf8\uce58\ub294 \uc601\ud5a5<\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">\uaddc\uc81c \ubcc0\ud654\uc758 \ud30c\uae09 \ud6a8\uacfc\ub294 \uc81c\uc870\uc5c5\uccb4\ub97c \ud6e8\uc52c \ub118\uc5b4\uc12d\ub2c8\ub2e4. \ub300\ub7c9 \uad6c\ub9e4\uc790, \uacf5\uae09\ub9dd \uad00\ub9ac\uc790 \ubc0f \uc7ac\ud310\ub9e4\uc790 \ub124\ud2b8\uc6cc\ud06c\ub294 \uadf8\uc5d0 \ub530\ub77c \uc870\ub2ec \ubc0f \uaddc\uc815 \uc900\uc218 \uc804\ub7b5\uc744 \uc870\uc815\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\ub3c4\ub9e4 \uad6c\ub9e4\uc790\uc5d0 \ubbf8\uce58\ub294 \uc601\ud5a5<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\ubb38\uc11c \uc694\uad6c \uc0ac\ud56d \uc99d\uac00: \uad6c\ub9e4\uc790\ub294 CE, FDA, ISO \uc778\uc99d\uc11c \ubc0f \uc804\uccb4 \uae30\uc220 \ud30c\uc77c\uc5d0 \uc561\uc138\uc2a4\ud574\uc57c \ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\ud488\uc9c8 \uae30\ub300\uce58 \uc0c1\uc2b9: \uaddc\uc815\uc744 \uc900\uc218\ud558\uc9c0 \uc54a\uac70\ub098 \uc624\ub798\ub41c \uc7ac\uace0\ub294 \ud310\ub9e4\ud560 \uc218 \uc5c6\uac8c \ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\uacf5\uae09\uc5c5\uccb4 \uc2ec\uc0ac: \uad6c\ub9e4\uc790\ub294 \uc785\uc99d\ub41c \uaddc\uc81c \uc2e4\uc801\uc744 \uac00\uc9c4 \uc81c\uc870\uc5c5\uccb4\ub97c \uc6b0\uc120\uc2dc\ud574\uc57c \ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\uc720\ud1b5\uc5c5\uccb4\uc5d0 \ubbf8\uce58\ub294 \uc601\ud5a5<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uaddc\uc81c \ucc45\uc784: \uc720\ud1b5\uc5c5\uccb4\ub294 MDR \ubc0f FDA \uc9c0\uce68\uc5d0 \ub530\ub77c \uc810\uc810 \ub354 \uacbd\uc81c \uc6b4\uc601\uc790\ub85c \uac04\uc8fc\ub429\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\ub77c\ubca8\ub9c1 \ubc0f \uc5b8\uc5b4 \uc694\uad6c \uc0ac\ud56d: \uc720\ud1b5\uc5c5\uccb4\ub294 \ub2e4\uad6d\uc5b4 \ud3ec\uc7a5 \uaddc\uc815 \uc900\uc218\ub97c \ubcf4\uc7a5\ud574\uc57c \ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\ub370\uc774\ud130 \uad00\ub9ac: \uc720\ud1b5\uc5c5\uccb4\ub294 UDI \uae30\ub85d \ubc0f \ubc30\uce58 \ucd94\uc801\uc131\uc744 \uc720\uc9c0\ud574\uc57c \ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">OEM \ud30c\ud2b8\ub108\uc5d0 \ubbf8\uce58\ub294 \uc601\ud5a5<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uc804\uccb4 \uae30\uc220 \ubb38\uc11c \uc18c\uc720\uad8c: OEM\uc740 \uc790\uccb4 \uac1c\uc778 \ub77c\ubca8 \uc81c\ud488\uc774 \uc644\uc804\ud55c \ubb38\uc11c\ub85c \ub4b7\ubc1b\uce68\ub418\ub3c4\ub85d \ud574\uc57c \ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\ube0c\ub79c\ub529 \uc758\ubbf8: OEM \ube0c\ub79c\ub4dc \uc81c\ud488\uc740 \uaddc\uc815\uc744 \uc900\uc218\ud558\ub294 \ub77c\ubca8\ub9c1 \ubc0f \uc81c\uc870\uc5c5\uccb4 \uc815\ubcf4\ub97c \ud45c\uc2dc\ud574\uc57c \ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\uc7a5\uae30 \ud30c\ud2b8\ub108\uc2ed \uc704\ud5d8: \uaddc\uc815 \ubbf8\uc900\uc218\ub294 \uc81c\ud488 \uc0c1\uc7a5 \ud3d0\uc9c0 \ub610\ub294 \uc218\uc785 \uae08\uc9c0\ub85c \uc774\uc5b4\uc9c8 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\uccb4\ud06c\ub9ac\uc2a4\ud2b8: 2025\ub144\uc5d0 B2B \uad6c\ub9e4\uc790\uac00 \uacf5\uae09\uc5c5\uccb4\uc5d0 \uc694\uccad\ud574\uc57c \ud560 \uc0ac\ud56d<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2705 ISO 13485 \ubc0f ISO 9001 \uc778\uc99d<br>\u2705 \ubbf8\uad6d FDA \ub4f1\ub85d \ubc0f 510(k) \uc2b9\uc778(\ud574\ub2f9\ud558\ub294 \uacbd\uc6b0)<br>\u2705 MDR\uc5d0 \ub530\ub978 EU CE \uc778\uc99d\uc11c(MDD \uc544\ub2d8)<br>\u2705 UDI \uc900\uc218 \ub77c\ubca8\ub9c1 \ubc0f \ud3ec\uc7a5<br>\u2705 \uba78\uade0 \uc720\ud6a8\uc131 \uac80\uc0ac \ubcf4\uace0\uc11c<br>\u2705 \uc0dd\uccb4 \uc801\ud569\uc131 \ubc0f \uc138\ud3ec \ub3c5\uc131 \ud14c\uc2a4\ud2b8 \ubcf4\uace0\uc11c<br>\u2705 GMP \uac10\uc0ac \ubcf4\uace0\uc11c (\ud2b9\ud788 \uc911\uad6d \uae30\ubc18 \uacf5\uc7a5\uc5d0 \ub300\ud55c)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\uc774\ub7ec\ud55c \uc694\uad6c \uc0ac\ud56d\uc744 \uc900\uc218\ud568\uc73c\ub85c\uc368 \ub3c4\ub9e4 \uad6c\ub9e4\uc790\uc640 OEM \ud30c\ud2b8\ub108\ub294 \ube44\uc6a9\uc774 \ub9ce\uc774 \ub4dc\ub294 \uc911\ub2e8\uc744 \ubc29\uc9c0\ud558\uace0, \uc911\ub2e8 \uc5c6\ub294 \uacf5\uae09\uc744 \ubcf4\uc7a5\ud558\uba70, \ucd5c\uc885 \uc0ac\uc6a9\uc790\uc640\uc758 \uc2e0\ub8b0\ub97c \uc720\uc9c0\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<ol start=\"4\" class=\"wp-block-list\">\n<li>2025\ub144\uc5d0 \uc8fc\ubaa9\ud574\uc57c \ud560 \uc8fc\uc694 \uc778\uc99d \ubc0f \uaddc\uc815 \uc900\uc218 \ud45c\uc900(FDA, MDR, ISO)<\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">\uc804 \uc138\uacc4 \uc2dc\uc7a5\uc5d0\uc11c \uaddc\uc81c \ud504\ub808\uc784\uc6cc\ud06c\uac00 \uac15\ud654\ub428\uc5d0 \ub530\ub77c \uc758\ub8cc\uc6a9 \uba74\ubd09 \ubc0f \ube0c\ub7ec\uc2dc \uacf5\uae09\ub9dd\uc758 \ubaa8\ub4e0 \ud50c\ub808\uc774\uc5b4\uc5d0\uac8c \uc778\uc99d \ubc0f \uaddc\uc815 \uc900\uc218 \ud45c\uc900\uc774 \ud544\uc218 \uc0ac\ud56d\uc774 \ub418\uace0 \uc788\uc2b5\ub2c8\ub2e4. \ubcd1\uc6d0, \uc2e4\ud5d8\uc2e4 \ub610\ub294 \ud0c0\uc0ac \ub9c8\ucf13\ud50c\ub808\uc774\uc2a4\uc5d0\uc11c \uc18c\uc2f1\ud558\ub4e0, \uc774\ub7ec\ud55c \ud45c\uc900\uc744 \uc774\ud574\ud558\ub294 \uac83\uc740 \uc704\ud5d8\uc744 \uc644\ud654\ud558\uace0 \uc81c\ud488\uc758 \uc0dd\uc874 \uac00\ub2a5\uc131\uc744 \ubcf4\uc7a5\ud558\ub294 \ub370 \ud544\uc218\uc801\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">2025\ub144\uc5d0 \uc870\ub2ec \ubc0f \uacf5\uae09\uc5c5\uccb4 \ud30c\ud2b8\ub108\uc2ed\uc744 \ud615\uc131\ud560 \uc138 \uac00\uc9c0 \uac00\uc7a5 \uc911\uc694\ud55c \ud45c\uc900 \uc138\ud2b8\ub97c \uc790\uc138\ud788 \uc0b4\ud3b4\ubcf4\uaca0\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A. FDA \uaddc\uc815(\ubbf8\uad6d)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\ubbf8\uad6d \uc2dd\ud488\uc758\uc57d\uad6d(FDA)\uc740 \uc758\ub8cc\uc6a9 \uba74\ubd09 \ubc0f \ube0c\ub7ec\uc2dc\uac00 \uc758\ub3c4\ub41c \uc6a9\ub3c4\uc5d0 \ub530\ub77c Class I \ub610\ub294 Class II \uc758\ub8cc \uae30\uae30 \ud45c\uc900\uc744 \uc900\uc218\ud558\ub3c4\ub85d \uc694\uad6c\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\uc8fc\uc694 2025\ub144 FDA \uc694\uad6c \uc0ac\ud56d:<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\uc694\uad6c \uc0ac\ud56d<\/th><th>\uc124\uba85<\/th><th>\uc601\ud5a5\uc744 \ubc1b\ub294 \uc0ac\ub78c<\/th><\/tr><\/thead><tbody><tr><td>UDI \uc900\uc218<\/td><td>\ubaa8\ub4e0 \uc7a5\uce58\uc5d0\ub294 \uace0\uc720 \uc7a5\uce58 \uc2dd\ubcc4\uc790\uac00 \uc788\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/td><td>\uc81c\uc870\uc5c5\uccb4, \uc218\uc785\uc5c5\uccb4, \uc720\ud1b5\uc5c5\uccb4<\/td><\/tr><tr><td>eSTAR \uc81c\ucd9c<\/td><td>510(k) \ubc0f PMN\uc5d0 \ub300\ud55c \ud544\uc218 \uc804\uc790 \ud615\uc2dd<\/td><td>OEM, \uacf5\uae09\uc5c5\uccb4<\/td><\/tr><tr><td>\uc0dd\uccb4 \uc801\ud569\uc131 \ud14c\uc2a4\ud2b8<\/td><td>\ud53c\ubd80\/\uc810\ub9c9 \uc811\ucd09\uc5d0 \ub300\ud55c ISO 10993-1 \uae30\ubc18<\/td><td>\ubaa8\ub4e0 \uacf5\uae09\uc5c5\uccb4 \ubc0f OEM<\/td><\/tr><tr><td>\uba78\uade0 \ubcf4\uc99d<\/td><td>\uac80\uc99d\ub41c \uba78\uade0 \ubc29\ubc95 \uc99d\uba85<\/td><td>\uc81c\uc870\uc5c5\uccb4<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">FDA \ub4f1\ub85d \ud544\uc218 \uc0ac\ud56d:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uc2dc\uc124 \ub4f1\ub85d<\/li>\n\n\n\n<li>\uc7a5\uce58 \ubaa9\ub85d<\/li>\n\n\n\n<li>\ub77c\ubca8\ub9c1 \uaddc\uc815 \uc900\uc218<\/li>\n\n\n\n<li>\uc6b0\uc218 \uc81c\uc870 \uad00\ub9ac \uae30\uc900(GMP)<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">B. MDR \uc900\uc218(\uc720\ub7fd \uc5f0\ud569)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\uc758\ub8cc \uae30\uae30 \uaddc\uc815(MDR 2017\/745)\uc740 \uc758\ub8cc \uae30\uae30 \uc9c0\uce68(MDD)\uc744 \ub300\uccb4\ud558\uba70 Class I \ubc0f IIa \uc7a5\uce58\uc5d0 \ub300\ud55c \ub354 \uc5c4\uaca9\ud55c \uad00\ub9ac\ub97c \uc694\uad6c\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\uc8fc\uc694 MDR 2025 \uc5c5\ub370\uc774\ud2b8:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\ubaa8\ub4e0 \uba74\ubd09 \ubc0f \ube0c\ub7ec\uc2dc\ub294 MDR \ubd80\uc18d\uc11c I \uc77c\ubc18 \uc548\uc804 \ubc0f \uc131\ub2a5 \uc694\uad6c \uc0ac\ud56d(GSPR)\uc744 \ucda9\uc871\ud574\uc57c \ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\uc2dc\ud310 \ud6c4 \uac10\uc2dc(PMS)\ub294 \uc720\ud1b5\uc5c5\uccb4\uc5d0\uc11c\ub3c4 \ubb38\uc11c\ud654\ud574\uc57c \ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\uc7a5\uce58\ub294 EU\uc758 \uc758\ub8cc \uae30\uae30 \uc911\uc559 \ub370\uc774\ud130\ubca0\uc774\uc2a4\uc778 EUDAMED\uc5d0 \ub4f1\ub85d\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">EU \uc720\ud1b5\uc5d0 \ub300\ud55c \uc778\uc99d \uc694\uad6c \uc0ac\ud56d:<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\uc778\uc99d\uc11c<\/th><th>\ubaa9\uc801<\/th><th>\ubc1c\ud589 \uae30\uad00<\/th><\/tr><\/thead><tbody><tr><td>MDR\uc5d0 \ub530\ub978 CE \ub9c8\ud0b9<\/td><td>EU \uaddc\uce59 \uc900\uc218 \uc5ec\ubd80 \ud45c\uc2dc<\/td><td>\uacf5\uc778 \uae30\uad00<\/td><\/tr><tr><td>\uc801\ud569\uc131 \uc120\uc5b8<\/td><td>\uc900\uc218 \ubc95\uc801 \uc9c4\uc220<\/td><td>\uc81c\uc870\uc5c5\uccb4<\/td><\/tr><tr><td>UDI-DI \ubc0f UDI-PI<\/td><td>\uc7a5\uce58 \ucd94\uc801\uc131 \ubc0f \ubc84\uc804 \uad00\ub9ac<\/td><td>\uc81c\uc870\uc5c5\uccb4<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">C. ISO \uc778\uc99d(\uae00\ub85c\ubc8c)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ISO \ud45c\uc900\uc740 \uc804 \uc138\uacc4\uc801\uc73c\ub85c \uc81c\ud488 \ud488\uc9c8, \ucd94\uc801\uc131 \ubc0f \ud504\ub85c\uc138\uc2a4 \ubb34\uacb0\uc131\uc744 \ubcf4\uc7a5\ud569\ub2c8\ub2e4. \uc758\ub8cc\uc6a9 \uba74\ubd09 \ubc0f \ube0c\ub7ec\uc2dc \uacf5\uae09\uc5c5\uccb4\uc758 \uacbd\uc6b0 \ub2e4\uc74c \uc778\uc99d\uc774 \uc911\uc694\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>ISO 13485: \uc758\ub8cc \uae30\uae30 \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c<\/li>\n\n\n\n<li>ISO 9001: \uc77c\ubc18 \ud488\uc9c8 \uad00\ub9ac<\/li>\n\n\n\n<li>ISO 10993-1: \uc0dd\uccb4 \uc801\ud569\uc131 \ud14c\uc2a4\ud2b8<\/li>\n\n\n\n<li>ISO 11135 \ub610\ub294 11137: \uba78\uade0 \uac80\uc99d(ETO \ub610\ub294 \uac10\ub9c8)<\/li>\n<\/ul>\n\n\n\n<figure class=\"wp-block-embed aligncenter is-type-wp-embed is-provider-hanheng-medical wp-block-embed-hanheng-medical\"><div class=\"wp-block-embed__wrapper\">\n<blockquote class=\"wp-embedded-content\" data-secret=\"TYwVcgHcfj\"><a href=\"https:\/\/hanheng-medical.com\/ko\/product\/vagianl-swab-bacterial-vaginosis-yeast-infections-sexually-transmitted-infections-8321\/\">\uc9c8 \uba74\ubd09\/\uc138\uade0\uc131 \uc9c8\uc5fc\/\uce78\ub514\ub2e4\uc99d\/\uc131\ubcd1 8321<\/a><\/blockquote><iframe loading=\"lazy\" class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"\u201c\uc9c8 \uba74\ubd09 \/ \uc138\uade0\uc131 \uc9c8\uc5fc \/ \uce78\ub514\ub2e4 \uc9c8\uc5fc \/ \uc131\ubcd1 8321\u201d \u2014 \ud55c\ud5dd \uba54\ub514\uceec\" src=\"https:\/\/hanheng-medical.com\/product\/vagianl-swab-bacterial-vaginosis-yeast-infections-sexually-transmitted-infections-8321\/embed\/#?secret=yxmCHcD4vq#?secret=TYwVcgHcfj\" data-secret=\"TYwVcgHcfj\" width=\"600\" height=\"338\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe>\n<\/div><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">B2B \uad6c\ub9e4\uc790\uc5d0\uac8c ISO 13485\uac00 \uc911\uc694\ud55c \uc774\uc720:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uc77c\uad00\ub41c \uc81c\ud488 \ud488\uc9c8\uc744 \ubcf4\uc7a5\ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\uc81c\ud488 \uc218\uba85 \uc8fc\uae30 \uc804\ubc18\uc5d0 \uac78\uccd0 \uc704\ud5d8 \uad00\ub9ac\ub97c \uc758\ubb34\ud654\ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\uc804 \uc138\uacc4 \uaddc\uc81c \uae30\uad00(FDA, EU MDR, NMPA)\uc5d0\uc11c \uc778\uc815\ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">2025\ub144 B2B \uc870\ub2ec\uc744 \uc704\ud55c \uaddc\uc815 \uc900\uc218 \uc900\ube44 \ubb38\uc11c \uccb4\ud06c\ub9ac\uc2a4\ud2b8:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2705 CE \uc778\uc99d\uc11c(MDR\uc5d0 \ub530\ub984)<br>\u2705 FDA 510(k) \ub610\ub294 \ub4f1\ub85d<br>\u2705 ISO 13485 \ubc0f 9001 \uc778\uc99d<br>\u2705 \uc0dd\uccb4 \uc801\ud569\uc131 \ud14c\uc2a4\ud2b8 \ubcf4\uace0\uc11c<br>\u2705 \uba78\uade0 \uac80\uc99d \ubb38\uc11c<br>\u2705 \ub77c\ubca8\ub9c1 \ubc0f UDI \uc900\uc218<br>\u2705 \uae30\uc220 \ud30c\uc77c \ubc0f \uc801\ud569\uc131 \uc120\uc5b8<\/p>\n\n\n\n<ol start=\"5\" class=\"wp-block-list\">\n<li>2025\ub144 \uaddc\uc815\uc744 \uc900\uc218\ud558\ub294 \uc8fc\uc694 \ub3c4\ub9e4 \uc758\ub8cc\uc6a9 \uba74\ubd09 \ubc0f \ube0c\ub7ec\uc2dc \uc81c\uc870\uc5c5\uccb4<\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">\uc801\uc808\ud55c \uacf5\uae09\uc5c5\uccb4\ub97c \uc120\ud0dd\ud558\ub294 \uac83\uc740 \uaddc\uc815 \uc900\uc218\ub97c \uc720\uc9c0\ud558\uace0, \ucc45\uc784\uc744 \ucd5c\uc18c\ud654\ud558\uba70, \uc6d0\ud65c\ud55c \uc218\uc785\/\uc218\ucd9c \uc6b4\uc601\uc744 \ubcf4\uc7a5\ud558\ub294 \ub370 \uc911\uc694\ud569\ub2c8\ub2e4. \ub2e4\uc74c\uc740 2025\ub144 \ud45c\uc900\uc5d0 \uc774\ubbf8 \ubd80\ud569\ud558\ub294 \uc8fc\uc694 \uae00\ub85c\ubc8c \uc81c\uc870\uc5c5\uccb4\uc758 \uc5c4\uc120\ub41c \ubaa9\ub85d\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\ud83c\udf0f FDA, MDR \ubc0f ISO \ud45c\uc900\uc744 \uc900\uc218\ud558\ub294 \uae00\ub85c\ubc8c \uc81c\uc870\uc5c5\uccb4<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\ud68c\uc0ac<\/th><th>\uad6d\uac00<\/th><th>\uc8fc\uc694 \uc778\uc99d<\/th><th>\uc81c\ud488 \uc911\uc810<\/th><th>\uc5f0\ub77d\ucc98<\/th><\/tr><\/thead><tbody><tr><td><a href=\"https:\/\/hanheng-medical.com\/ko\/\">\uac15\uc18c \ud55c\ud765 \uc758\ub8cc \uae30\uc220 \uc720\ud55c \uacf5\uc0ac<\/a><\/td><td>\uc911\uad6d<\/td><td>ISO 13485, ISO 9001, CE(MDR), FDA<\/td><td>\ube44\uac15 \uba74\ubd09, \uc790\uad81 \uacbd\ubd80 \ube0c\ub7ec\uc2dc, \ubd80\uc778\uacfc \ud0a4\ud2b8<\/td><td><a href=\"https:\/\/hanheng-medical.com\/ko\/\" target=\"_blank\" rel=\"noreferrer noopener\">www.hanheng-medical.com<\/a><\/td><\/tr><tr><td>\ucf54\ud310 \uc9c4\ub2e8<\/td><td>\ubbf8\uad6d<\/td><td>ISO 13485, FDA, CE<\/td><td>\ud50c\ub85d \uba74\ubd09, \uc6b4\uc1a1 \ubc30\uc9c0<\/td><td><a href=\"http:\/\/www.copanusa.com\/\" target=\"_blank\" rel=\"noreferrer noopener\">www.copanusa.com<\/a><\/td><\/tr><tr><td>\ud4e8\ub9ac\ud0c4 \uc758\ub8cc \uc81c\ud488<\/td><td>\ubbf8\uad6d<\/td><td>FDA, ISO 13485, CE<\/td><td>\uc9c4\ub2e8 \ubc0f \uc5f0\uad6c\uc6a9 \uba74\ubd09<\/td><td><a href=\"http:\/\/www.puritanmedproducts.com\/\" target=\"_blank\" rel=\"noreferrer noopener\">www.puritanmedproducts.com<\/a><\/td><\/tr><tr><td>MWE(Medical Wire)<\/td><td>UK<\/td><td>MDR CE, ISO 9001, ISO 13485<\/td><td>\uac80\uccb4 \ucc44\ucde8 \ubc0f \uc6b4\uc1a1<\/td><td><a href=\"http:\/\/www.mwe.co.uk\/\" target=\"_blank\" rel=\"noreferrer noopener\">www.mwe.co.uk<\/a><\/td><\/tr><tr><td>Deltalab<\/td><td>\uc2a4\ud398\uc778<\/td><td>ISO 13485, CE, FDA<\/td><td>\uc77c\ubc18 \uc2e4\ud5d8\uc2e4 \uc18c\ubaa8\ud488, \uba74\ubd09<\/td><td><a href=\"http:\/\/www.deltalab.es\/\" target=\"_blank\" rel=\"noreferrer noopener\">www.deltalab.es<\/a><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\uc911\uad6d \uaddc\uc81c \uc900\uc218 \ubd84\uc57c\uc5d0\uc11c \uc7a5\uc464 \ud55c\ud5dd\uc774 \uc120\ub450\ub97c \ub2ec\ub9ac\ub294 \uc774\uc720<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\uc800\ud76c\uac00 \ucd94\ucc9c\ud558\ub294 \uc720\uc77c\ud55c \uc911\uad6d \uc81c\uc870\uc5c5\uccb4\ub85c\uc11c, <a href=\"https:\/\/hanheng-medical.com\/ko\/about-us\/\">\uac15\uc18c \ud55c\ud765 \uc758\ub8cc \uae30\uc220 \uc720\ud55c \uacf5\uc0ac<\/a> \uc644\uc804\ud55c \uaddc\uc815 \uc900\uc218\ub97c \uc6d0\ud558\ub294 \uad6d\uc81c \uad6c\ub9e4\uc790\uc5d0\uac8c \uc758\ub8cc\uc6a9 \uba74\ubd09 \ubc0f \ube0c\ub7ec\uc2dc \uc194\ub8e8\uc158\uc73c\ub85c \ub450\uac01\uc744 \ub098\ud0c0\ub0b4\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\uc8fc\uc694 \uaddc\uc815 \uc900\uc218 \ud2b9\uc9d5:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>ISO 13485 \ubc0f ISO 9001 \uc778\uc99d<\/li>\n\n\n\n<li>EU CE \uc778\uc99d\uc11c(MDR \uc900\uc218)<\/li>\n\n\n\n<li>UDI \ub77c\ubca8\ub9c1\uc73c\ub85c FDA \ub4f1\ub85d<\/li>\n\n\n\n<li>10,000\u33a1 Class 100,000 \ud074\ub9b0\ub8f8\uc5d0\uc11c \uba78\uade0 \uc0dd\uc0b0<\/li>\n\n\n\n<li>\uc644\uc804\ud55c \uae30\uc220 \ubb38\uc11c\ub97c \uc704\ud55c \uc0ac\ub0b4 R&amp;D \ubc0f QA \ud300<\/li>\n<\/ul>\n\n\n\n<figure class=\"wp-block-embed aligncenter is-type-wp-embed is-provider-hanheng-medical wp-block-embed-hanheng-medical\"><div class=\"wp-block-embed__wrapper\">\n<blockquote class=\"wp-embedded-content\" data-secret=\"eid2U7BhN9\"><a href=\"https:\/\/hanheng-medical.com\/ko\/product\/cytological-brush-pap-smear-chlamydia-hpv-screening-ayre-spatula-protective-bulb-tip-8101b30\/\">\uc138\ud3ec\ud559\uc801 \ube0c\ub7ec\uc2dc\/\uc790\uad81\uacbd\ubd80 \ub3c4\ub9d0 \uac80\uc0ac\/\ud074\ub77c\ubbf8\ub514\uc544\/HPV \uac80\uc0ac\/Ayre Spatula\/\ubcf4\ud638\uc6a9 \uc804\uad6c \ud301 8101B30<\/a><\/blockquote><iframe loading=\"lazy\" class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"\u201c\uc138\ud3ec\ud559\uc801 \ube0c\ub7ec\uc2dc\/\ud30c\ud30c \uc2a4\ubbf8\uc5b4\/\ud074\ub77c\ubbf8\ub514\uc544\/HPV \uac80\uc0ac\/Ayre \uc2a4\ud30c\uce0c\ub77c\/\ubcf4\ud638\uc6a9 \uad6c\uadfc \ud301 8101B30\u201d \u2014 \ud55c\ud5dd \uba54\ub514\uceec\" src=\"https:\/\/hanheng-medical.com\/product\/cytological-brush-pap-smear-chlamydia-hpv-screening-ayre-spatula-protective-bulb-tip-8101b30\/embed\/#?secret=InH3w2jDzb#?secret=eid2U7BhN9\" data-secret=\"eid2U7BhN9\" width=\"600\" height=\"338\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe>\n<\/div><\/figure>\n\n\n\n<ol start=\"6\" class=\"wp-block-list\">\n<li>\ub354 \ub9ce\uc740 \uad6c\ub9e4\uc790\uac00 \uaddc\uc815 \uc900\uc218 \ubc0f \uacbd\uc81c\uc131\uc744 \uc704\ud574 \uc911\uad6d \uc81c\uc870\uc5c5\uccb4\ub97c \uc120\ud0dd\ud558\ub294 \uc774\uc720<\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">\ucd5c\uadfc \uba87 \ub144 \ub3d9\uc548 \uc911\uad6d \uc81c\uc870\uc5c5\uccb4\ub294 \ud488\uc9c8 \ubcf4\uc99d, \uaddc\uc815 \uc900\uc218 \ubc0f \uc0dd\uc0b0 \ud655\uc7a5\uc131\uc5d0\uc11c \uc0c1\ub2f9\ud55c \ubc1c\uc804\uc744 \uc774\ub8e8\uc5b4 \ub3c4\ub9e4 \uad6c\ub9e4\uc790\uc640 \uae00\ub85c\ubc8c \uc720\ud1b5\uc5c5\uccb4\uc5d0\uac8c \uc810\uc810 \ub354 \ub9e4\ub825\uc801\uc778 \uc874\uc7ac\uac00 \ub418\uc5c8\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\uc911\uad6d\uc774 B2B \ub9ac\ub354\ub85c \ubd80\uc0c1\ud558\ub294 \uc774\uc720:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\ucca8\ub2e8 \uc81c\uc870 \uc778\ud504\ub77c: \ud074\ub9b0\ub8f8\uacfc \uc790\ub3d9\ud654\ub41c \uc0dd\uc0b0 \ub77c\uc778\uc744 \uac16\ucd98 \ucd5c\uc2e0 \uc2dc\uc124.<\/li>\n\n\n\n<li>\ube44\uc6a9 \ud6a8\uc728\uc131: \ud488\uc9c8 \uc800\ud558 \uc5c6\uc774 \ub0ae\uc740 \uc778\uac74\ube44 \ubc0f \uc6b4\uc601 \ube44\uc6a9.<\/li>\n\n\n\n<li>\uaddc\uc81c \uc5c5\uadf8\ub808\uc774\ub4dc: \ub9ce\uc740 \uacf5\uc7a5\uc774 \ud604\uc7ac ISO13485 \uc778\uc99d \ubc0f FDA \ub4f1\ub85d\uc744 \ubc1b\uc558\uc2b5\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\uc2e0\uc18d\ud55c \uc0dd\uc0b0 \ubc0f \ubc30\uc1a1: \uae00\ub85c\ubc8c \ubb3c\ub958 \ud5c8\ube0c\uc640\uc758 \uadfc\uc811\uc131\uc73c\ub85c \uc778\ud55c \ub354 \ube60\ub978 \ub9ac\ub4dc \ud0c0\uc784.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\ube44\uad50\ud45c: \ubbf8\uad6d vs \uc720\ub7fd vs \uc911\uad6d \uc81c\uc870\uc5c5\uccb4<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\uae30\ub2a5<\/th><th>\ubbf8\uad6d \uacf5\uae09\uc5c5\uccb4<\/th><th>EU \uacf5\uae09\uc5c5\uccb4<\/th><th>\uc7a5\uc464 \ud55c\ud5dd(\uc911\uad6d)<\/th><\/tr><\/thead><tbody><tr><td>ISO 13485 \uc778\uc99d<\/td><td>\u2705<\/td><td>\u2705<\/td><td>\u2705<\/td><\/tr><tr><td>FDA \ub4f1\ub85d<\/td><td>\u2705<\/td><td>\u2705<\/td><td>\u2705<\/td><\/tr><tr><td>CE MDR \uc900\uc218<\/td><td>\u2705<\/td><td>\u2705<\/td><td>\u2705<\/td><\/tr><tr><td>\ube44\uc6a9 \ud6a8\uc728\uc131<\/td><td>\u274c \ub192\uc74c<\/td><td>\u274c \ub192\uc74c<\/td><td>\u2705 \uacbd\uc7c1\ub825 \uc788\uc74c<\/td><\/tr><tr><td>\ub9de\ucda4\ud615 OEM \uc11c\ube44\uc2a4<\/td><td>\u2705<\/td><td>\u2705<\/td><td>\u2705<\/td><\/tr><tr><td>\ub9ac\ub4dc \ud0c0\uc784<\/td><td>4\u20136\uc8fc<\/td><td>4\u20138\uc8fc<\/td><td>2\u20134\uc8fc<\/td><\/tr><tr><td>MOQ \uc720\uc5f0\uc131<\/td><td>\uc911\uac04<\/td><td>\ub0ae\uc74c<\/td><td>\u2705 \ub192\uc74c<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">B2B \uad6c\ub9e4\uc790\uac00 \ud55c\ud5dd\uc73c\ub85c \uc804\ud658\ud558\ub294 \uc774\uc720:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>FDA, MDR, ISO \ud45c\uc900\uc744 \uc644\ubcbd\ud558\uac8c \uc900\uc218<\/li>\n\n\n\n<li>\ube44\uac15 \uba74\ubd09, \uc790\uad81\uacbd\ubd80 \ube0c\ub7ec\uc2dc \ubc0f \uc0d8\ud50c \uc218\uc9d1 \ud0a4\ud2b8\ub97c \ud3ec\ud568\ud55c \uad11\ubc94\uc704\ud55c \uc81c\ud488\uad70<\/li>\n\n\n\n<li>OEM \ubc0f \uc790\uccb4 \ube0c\ub79c\ub4dc \ud3ec\uc7a5 \uc635\uc158<\/li>\n\n\n\n<li>\ube60\ub978 \ucc98\ub9ac \ubc0f \uae00\ub85c\ubc8c \ubc30\uc1a1 \uae30\ub2a5<\/li>\n\n\n\n<li>\ubb38\uc11c \ubc0f \uc778\uc99d \uac10\uc0ac\uc5d0 \ub300\ud55c \uc804\ub2f4 \uc9c0\uc6d0<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\ubcd1\uc6d0 \uadf8\ub8f9, \uc9c4\ub2e8 \uc2e4\ud5d8\uc2e4 \ub610\ub294 \uc720\ud1b5\uc5c5\uccb4\uc774\ub4e0, \uc7a5\uc464 \ud55c\ud5dd\uacfc \uac19\uc740 \uc2e0\ub8b0\ud560 \uc218 \uc788\uace0 \uc644\uc804\ud55c \uaddc\uc815 \uc900\uc218 \uc911\uad6d \uacf5\uae09\uc5c5\uccb4\uc640 \ud611\ub825\ud558\uba74 \ube44\uc6a9\uc744 \ucd5c\uc801\ud654\ud558\uba74\uc11c \uaddc\uc81c \ubcc0\ud654\ub97c \uc55e\uc11c \ub098\uac08 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<ol start=\"7\" class=\"wp-block-list\">\n<li>\uaddc\uc815 \uc900\uc218 \uc758\ub8cc\uc6a9 \uba74\ubd09 \ubc0f \ube0c\ub7ec\uc2dc\uc758 \uc2e0\ub8b0\ud560 \uc218 \uc788\ub294 \uacf5\uae09\uc5c5\uccb4\ub85c \uc7a5\uc464 \ud55c\ud5dd\uc744 \uc120\ud0dd\ud574\uc57c \ud558\ub294 \uc774\uc720<\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">\uc5ed\ub3d9\uc801\uc778 \uae00\ub85c\ubc8c \uaddc\uc81c \ud658\uacbd\uc5d0\uc11c \uaddc\uc815 \uc900\uc218 \ud45c\uc900\uc744 \ucda9\uc871\ud560 \ubfd0\ub9cc \uc544\ub2c8\ub77c \uc774\ub97c \ub2a5\uac00\ud558\ub294 \uacf5\uae09\uc5c5\uccb4\ub97c \uc120\ud0dd\ud558\ub294 \uac83\uc740 B2B \uad6c\ub9e4\uc790\uc5d0\uac8c \ub9e4\uc6b0 \uc911\uc694\ud569\ub2c8\ub2e4. \uc7a5\uc464 \ud55c\ud5dd \uc758\ub8cc \uae30\uc220 \uc720\ud55c \ud68c\uc0ac\ub294 \uc758\ub8cc\uc6a9 \uba74\ubd09 \ubc0f \ube0c\ub7ec\uc2dc\uc758 \ucd5c\uace0\uc758 \uc81c\uc870\uc5c5\uccb4\ub85c \ub450\uac01\uc744 \ub098\ud0c0\ub0b4\uba70 \ub3c4\ub9e4 \uad6c\ub9e4\uc790, \uc720\ud1b5\uc5c5\uccb4 \ubc0f OEM \ud30c\ud2b8\ub108\uc5d0\uac8c \ub9de\ucda4\ud654\ub41c \ud0c1\uc6d4\ud55c \ud488\uc9c8, \uaddc\uc81c \ubcf4\uc99d \ubc0f B2B \uc9c0\uc6d0\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">2025\ub144 \uaddc\uc81c \ud658\uacbd\uc744 \ud0d0\uc0c9\ud558\ub294 \uad6c\ub9e4\uc790\uc5d0\uac8c \uc7a5\uc464 \ud55c\ud5dd\uc774 \uc120\ud638\ub418\ub294 \uc774\uc720\ub97c \uc0b4\ud3b4\ubcf4\uaca0\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u2705 2025\ub144 \uae00\ub85c\ubc8c \ud45c\uc900\uc744 \uc644\ubcbd\ud558\uac8c \uc900\uc218<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\ud55c\ud5dd\uc758 \uc81c\uc870 \ubc0f \ud488\uc9c8 \uc2dc\uc2a4\ud15c\uc740 \ucd5c\uc2e0 \uad6d\uc81c \uaddc\uc81c \uc5c5\ub370\uc774\ud2b8\uc5d0 \ub9de\ucdb0 \uad6c\ucd95\ub418\uc5c8\uc2b5\ub2c8\ub2e4. \uc774\ub97c \ud1b5\ud574 \ubaa8\ub4e0 \uc81c\ud488\uc774 \uc784\uc0c1 \uc0ac\uc6a9\uc5d0 \uc801\ud569\ud558\uace0, \uc218\uc785 \uac00\ub2a5\ud558\uba70, \uc548\uc804\ud558\uac8c \uc720\uc9c0\ub429\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\uc778\uc99d \ubc0f \uaddc\uc815 \uc900\uc218:<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\uc778\uc99d<\/th><th>\ucda9\uc871\ub41c \ud45c\uc900<\/th><th>\ucca8\ub2e8 R&amp;D<\/th><\/tr><\/thead><tbody><tr><td>ISO 13485<\/td><td>\uc758\ub8cc \uae30\uae30 QMS<\/td><td>\uc77c\uad00\ub41c \uc81c\ud488 \ud488\uc9c8 \ubcf4\uc7a5<\/td><\/tr><tr><td>ISO 9001<\/td><td>\uc77c\ubc18 QMS<\/td><td>\uc6b4\uc601 \uc6b0\uc218\uc131 \ubcf4\uc7a5<\/td><\/tr><tr><td>CE(MDR)<\/td><td>EU \uc758\ub8cc \uae30\uae30 \uaddc\uc815 2017\/745<\/td><td>\ubaa8\ub4e0 EU \ud68c\uc6d0\uad6d\uc5d0\uc11c \ud569\ubc95\uc801\uc778 \ud310\ub9e4<\/td><\/tr><tr><td>FDA \ub4f1\ub85d<\/td><td>\ubbf8\uad6d FDA<\/td><td>\ubbf8\uad6d \uc758\ub8cc \uc2dc\uc7a5 \uc811\uadfc<\/td><\/tr><tr><td>UDI \ub77c\ubca8\ub9c1<\/td><td>FDA, EU MDR<\/td><td>\ub9ac\ucf5c \ubc0f \uac10\uc0ac\uc5d0 \ub300\ud55c \ucd94\uc801\uc131 \uac1c\uc120<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\ud83d\udce6 \uc784\uc0c1 \uc815\ubc00\ub3c4\ub97c \uc704\ud574 \uc124\uacc4\ub41c \uad11\ubc94\uc704\ud55c \uc81c\ud488 \ud3ec\ud2b8\ud3f4\ub9ac\uc624<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\ud55c\ud5dd\uc740 \uc9c4\ub2e8, \ubd80\uc778\uacfc \ubc0f \uac10\uc5fc\uc131 \uc9c8\ud658 \uac80\uc0ac\uc5d0 \uc0ac\uc6a9\ub418\ub294 \ub2e4\uc591\ud55c \uba78\uade0 \uc758\ub8cc \uc18c\ubaa8\ud488\uc744 \uc81c\uc870\ud569\ub2c8\ub2e4. \uac01 \uc81c\ud488\uc740 \ucd5c\uc801\uc758 \uc0d8\ud50c \uc218\uc9d1, \ud658\uc790 \ud3b8\uc758\uc131 \ubc0f \uc2e4\ud5d8\uc2e4 \ud638\ud658\uc131\uc744 \uc704\ud574 \uc124\uacc4\ub418\uc5c8\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\uc81c\ud488 \uce74\ud14c\uace0\ub9ac:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\ube44\uc778\ub450 \ubc0f \uad6c\uac15 \uba74\ubd09<\/li>\n\n\n\n<li>\uba78\uade0 \uc790\uad81\uacbd\ubd80 \uc0d8\ud50c\ub9c1 \ube0c\ub7ec\uc2dc<\/li>\n\n\n\n<li>\uc77c\ud68c\uc6a9 \uc790\uad81\uacbd\ubd80 \uac80\uccb4 \ucc44\ucde8\uae30<\/li>\n\n\n\n<li>\uc9c8\uacbd \ubc0f \ubd80\uc778\uacfc \uc2a4\ud06c\ub808\uc774\ud37c<\/li>\n\n\n\n<li>\uc0d8\ud50c \uc218\uc9d1 \uc0c1\uc790 \ubc0f \ubcf4\uad00 \ud0a4\ud2b8<\/li>\n\n\n\n<li>\ubd80\uc778\uacfc \uac80\uc0ac \ud0a4\ud2b8<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\uac01 \uc81c\ud488\uc740 \uc5c4\uaca9\ud55c \uba78\uade0 \ubc0f \uc785\uc790 \uc81c\uc5b4\ub97c \ubcf4\uc7a5\ud558\uae30 \uc704\ud574 Class 100,000 \ud074\ub9b0\ub8f8 \ud658\uacbd\uc5d0\uc11c \uc81c\uc870\ub429\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\ud83d\udd2c \ub9de\ucda4\ud615 OEM \uc694\uad6c \uc0ac\ud56d\uc744 \uc704\ud55c R&amp;D \uc911\uc2ec \ud601\uc2e0<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\ud55c\ud5dd\uc758 \uc0ac\ub0b4 R&amp;D \ubd80\uc11c\ub294 \uae00\ub85c\ubc8c \uad6c\ub9e4\uc790\uc640 \uae34\ubc00\ud788 \ud611\ub825\ud558\uc5ec \uaddc\uc81c, \uc784\uc0c1 \ub610\ub294 \ube0c\ub79c\ub529 \uc694\uad6c \uc0ac\ud56d\uc5d0 \ub530\ub77c \uc0c8\ub85c\uc6b4 \uc81c\ud488\uc744 \uac1c\ubc1c\ud558\uac70\ub098 \uae30\uc874 \uc124\uacc4\ub97c \uc218\uc815\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">R&amp;D \uae30\ub2a5\uc5d0\ub294 \ub2e4\uc74c\uc774 \ud3ec\ud568\ub429\ub2c8\ub2e4.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\ub9de\ucda4\ud615 \uba74\ubd09 \ubaa8\uc591 \ubc0f \ube0c\ub7ec\uc2dc \ud06c\uae30\uc5d0 \ub300\ud55c \uc2e0\uc18d\ud55c \ud504\ub85c\ud1a0\ud0c0\uc785 \uc81c\uc791<\/li>\n\n\n\n<li>\ub2e4\uae30\ub2a5 \ubd80\uc778\uacfc \uc0d8\ud50c\ub9c1 \ud0a4\ud2b8 \uac1c\ubc1c<\/li>\n\n\n\n<li>UDI \uc900\uc218 \ub77c\ubca8\ub9c1 \uc2dc\uc2a4\ud15c \ud1b5\ud569<\/li>\n\n\n\n<li>\ud3ec\uc7a5 \uc0ac\uc6a9\uc790 \uc815\uc758: \uc790\uccb4 \ube0c\ub79c\ub4dc, \uc5b8\uc5b4 \ubcc0\ud615, \uba78\uade0 \ud30c\uc6b0\uce58<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\ud83d\udee0 \ud488\uc9c8 \uad00\ub9ac \ubc0f \ucd94\uc801\uc131 \uc2dc\uc2a4\ud15c<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\ud55c\ud5dd\uc740 \uc6d0\uc790\uc7ac \uac80\uc0ac, \uacf5\uc815 \uc911 \ud488\uc9c8 \ubcf4\uc99d \ubc0f \uc0dd\uc0b0 \ud6c4 \ud14c\uc2a4\ud2b8\ub97c \ud3ec\ud568\ud558\ub294 \ub2e4\ub2e8\uacc4 \ud488\uc9c8 \uad00\ub9ac \uc2dc\uc2a4\ud15c\uc744 \ubc30\ud3ec\ud569\ub2c8\ub2e4. \ubaa8\ub4e0 \ubc30\uce58\ub294 \uaddc\uc81c \uac10\uc0ac \ubc0f \ud604\uc7a5 \ub9ac\ucf5c\uc5d0 \ud544\uc218\uc801\uc778 \ub514\uc9c0\ud138 \ub85c\ud2b8 \ucf54\ub529\uc744 \ud1b5\ud574 \ucd94\uc801 \uac00\ub2a5\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\ud488\uc9c8 \uad00\ub9ac \ud558\uc774\ub77c\uc774\ud2b8:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uba78\uade0 \uc81c\ud488\uc758 100% \uc721\uc548 \uac80\uc0ac<\/li>\n\n\n\n<li>ISO 10993-1\uc5d0 \ub530\ub978 \uc0dd\uccb4 \uc801\ud569\uc131 \ubc0f \uc138\ud3ec \ub3c5\uc131 \ud14c\uc2a4\ud2b8<\/li>\n\n\n\n<li>EO \ub610\ub294 \uac10\ub9c8\uc120 \uc870\uc0ac\ub97c \uc0ac\uc6a9\ud55c \uba78\uade0 \uc720\ud6a8\uc131 \uac80\uc0ac<\/li>\n\n\n\n<li>UDI \uc900\uc218 \ubc14\ucf54\ub529\uc744 \uc0ac\uc6a9\ud55c \ubc30\uce58 \ucd94\uc801\uc131<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\ud83c\udf0d \uae00\ub85c\ubc8c \uc720\ud1b5 \uacbd\ud5d8<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\ud55c\ud5dd\uc740 \ubcd1\uc6d0 \uc870\ub2ec \uadf8\ub8f9, \uc9c4\ub2e8 \uc2e4\ud5d8\uc2e4 \uccb4\uc778, \uc758\ub8cc \ub3c4\ub9e4\uc5c5\uccb4 \ubc0f \uc804\uc790 \uc0c1\uac70\ub798 B2B \ud50c\ub7ab\ud3fc\uacfc \ud611\ub825\ud558\uc5ec 50\uac1c \uc774\uc0c1\uc758 \uad6d\uac00\uc5d0 \uc131\uacf5\uc801\uc73c\ub85c \uc218\ucd9c\ud588\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\uae00\ub85c\ubc8c \ub3c4\ub2ec \ubc94\uc704:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>EU: \ub3c5\uc77c, \ud504\ub791\uc2a4, \uc2a4\ud398\uc778, \uc774\ud0c8\ub9ac\uc544<\/li>\n\n\n\n<li>\ubd81\ubbf8: \ubbf8\uad6d, \uce90\ub098\ub2e4, \uba55\uc2dc\ucf54<\/li>\n\n\n\n<li>\uc544\uc2dc\uc544 \ud0dc\ud3c9\uc591: \ub300\ud55c\ubbfc\uad6d, \uc77c\ubcf8, \uc778\ub3c4, \uc544\uc138\uc548 \uad6d\uac00<\/li>\n\n\n\n<li>\uc911\ub3d9 \ubc0f \uc544\ud504\ub9ac\uce74: UAE, \uc774\uc9d1\ud2b8, \ub0a8\uc544\ud504\ub9ac\uce74 \uacf5\ud654\uad6d<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\ud55c\ud5dd\uc758 \ubb3c\ub958 \ud300\uc740 \uc218\ucd9c \ubb38\uc11c, \ud1b5\uad00 \ubc0f \uaddc\uc81c \ud30c\uc77c\ub9c1 \uc9c0\uc6d0\uc744 \ud1b5\ud574 \uc5d4\ub4dc \ud22c \uc5d4\ub4dc \uc9c0\uc6d0\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\ud83d\udce7 \uc804\ub2f4 B2B \uc9c0\uc6d0<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\ub3c4\ub9e4 \uad6c\ub9e4\uc790\ub97c \uc704\ud574 \ud55c\ud5dd\uc740 \ub2e4\uc74c\uc744 \uc704\ud55c \ub9de\ucda4\ud615 \uacc4\uc815 \uad00\ub9ac \ubc0f \uae30\uc220 \uc9c0\uc6d0\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uaddc\uc81c \uac10\uc0ac \ubc0f \ubb38\uc11c \uc900\ube44<\/li>\n\n\n\n<li>OEM \uc81c\ud488 \uac1c\ubc1c<\/li>\n\n\n\n<li>MOQ \ud611\uc0c1 \ubc0f \ub300\ub7c9 \ud560\uc778<\/li>\n\n\n\n<li>\uae00\ub85c\ubc8c \ubc30\uc1a1 \uc870\uc815<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">B2B \ubb38\uc758 \uc5f0\ub77d\ucc98:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\ud83c\udf10 \uc6f9\uc0ac\uc774\ud2b8: <a href=\"https:\/\/hanheng-medical.com\/ko\/\" target=\"_blank\" rel=\"noreferrer noopener\">www.hanheng-medical.com<\/a><\/li>\n\n\n\n<li>\ud83d\udce9 \uc774\uba54\uc77c: <a href=\"mailto:sales@hanhengmed.com\" target=\"_blank\" rel=\"noreferrer noopener\">sales@hanhengmed.com<\/a><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\ube44\uc6a9 \ud6a8\uc728\uc131\uacfc \uaddc\uc815 \uc900\uc218\ub97c \ubcf4\uc7a5\ud558\uba74\uc11c \uc81c\ud488 \uc18c\uc2f1 \uc804\ub7b5\uc744 \ubbf8\ub798 \uc9c0\ud5a5\uc801\uc73c\ub85c \ub9cc\ub4e4\ub824\ub294 \uad6c\ub9e4\uc790\ub294 \uc7a5\uc464 \ud55c\ud5dd\uc744 \uc7a5\uae30\uc801\uc778 \uc804\ub7b5\uc801 \ud30c\ud2b8\ub108\ub85c \uc0dd\uac01\ud560 \uac83\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<figure class=\"wp-block-gallery has-nested-images columns-default is-cropped wp-block-gallery-2 is-layout-flex wp-block-gallery-is-layout-flex\">\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" data-id=\"2441\" src=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/03\/Cytological-brushPap-SmearchlamydiaHPV-Screening-8101A01\u84dd2.jpg\" alt=\"\" class=\"wp-image-2441\" title=\"\" srcset=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/03\/Cytological-brushPap-SmearchlamydiaHPV-Screening-8101A01\u84dd2.jpg 800w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/03\/Cytological-brushPap-SmearchlamydiaHPV-Screening-8101A01\u84dd2-300x300.jpg 300w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/03\/Cytological-brushPap-SmearchlamydiaHPV-Screening-8101A01\u84dd2-150x150.jpg 150w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/03\/Cytological-brushPap-SmearchlamydiaHPV-Screening-8101A01\u84dd2-768x768.jpg 768w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" data-id=\"2451\" src=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/03\/Cytological-brushPap-SmearchlamydiaHPV-Screening8Reinforced-poleProtective-bulb-tip-8101B20-3.jpg\" alt=\"\" class=\"wp-image-2451\" title=\"\" srcset=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/03\/Cytological-brushPap-SmearchlamydiaHPV-Screening8Reinforced-poleProtective-bulb-tip-8101B20-3.jpg 800w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/03\/Cytological-brushPap-SmearchlamydiaHPV-Screening8Reinforced-poleProtective-bulb-tip-8101B20-3-300x300.jpg 300w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/03\/Cytological-brushPap-SmearchlamydiaHPV-Screening8Reinforced-poleProtective-bulb-tip-8101B20-3-150x150.jpg 150w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/03\/Cytological-brushPap-SmearchlamydiaHPV-Screening8Reinforced-poleProtective-bulb-tip-8101B20-3-768x768.jpg 768w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" data-id=\"2450\" src=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/03\/Cytological-brushPap-SmearchlamydiaHPV-Screening8Reinforced-poleProtective-bulb-tip-8101B20-2.jpg\" alt=\"\" class=\"wp-image-2450\" title=\"\" srcset=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/03\/Cytological-brushPap-SmearchlamydiaHPV-Screening8Reinforced-poleProtective-bulb-tip-8101B20-2.jpg 800w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/03\/Cytological-brushPap-SmearchlamydiaHPV-Screening8Reinforced-poleProtective-bulb-tip-8101B20-2-300x300.jpg 300w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/03\/Cytological-brushPap-SmearchlamydiaHPV-Screening8Reinforced-poleProtective-bulb-tip-8101B20-2-150x150.jpg 150w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/03\/Cytological-brushPap-SmearchlamydiaHPV-Screening8Reinforced-poleProtective-bulb-tip-8101B20-2-768x768.jpg 768w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/figure>\n<\/figure>\n\n\n\n<ol start=\"8\" class=\"wp-block-list\">\n<li>\uc0c8\ub85c\uc6b4 \uaddc\uc815\uc5d0 \ub530\ub77c \ub3c4\ub9e4 \uc758\ub8cc\uc6a9 \ube0c\ub7ec\uc2dc \ubc0f \uba74\ubd09\uc744 \uc8fc\ubb38\ud558\uae30 \uc704\ud55c \ub2e8\uacc4\ubcc4 \uac00\uc774\ub4dc<\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">2025\ub144 \uaddc\uc81c \ubcc0\uacbd \uc0ac\ud56d\uc774 \ud604\uc7ac \uc2dc\ud589\ub428\uc5d0 \ub530\ub77c \uaddc\uc815 \uc900\uc218 \uc758\ub8cc\uc6a9 \uba74\ubd09 \ubc0f \ube0c\ub7ec\uc2dc\ub97c \uc8fc\ubb38\ud558\uace0 \uc218\uc785\ud558\ub294 \ud504\ub85c\uc138\uc2a4\uc5d0 \uc0c8\ub85c\uc6b4 \ubcf5\uc7a1\uc131\uc774 \ucd94\uac00\ub418\uc5c8\uc2b5\ub2c8\ub2e4. \ub2e4\uc74c\uc740 \ubcd1\uc6d0 \uc870\ub2ec \ud300, \ub3c4\ub9e4\uc5c5\uccb4, \uc9c4\ub2e8 \uc2e4\ud5d8\uc2e4 \ubc0f OEM \ube0c\ub79c\ub4dc\ub97c \ud3ec\ud568\ud55c B2B \uad6c\ub9e4\uc790\ub97c \uc704\ud574 \ub9de\ucda4\ud654\ub41c \ub2e8\uacc4\ubcc4 \uc870\ub2ec \uac00\uc774\ub4dc\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\ud83e\uddfe 1\ub2e8\uacc4: \uc81c\ud488 \uc0ac\uc591 \ubc0f \uaddc\uc815 \uc900\uc218 \uc694\uad6c \uc0ac\ud56d \uc815\uc758<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\uc751\uc6a9 \ubd84\uc57c\uc5d0 \ub530\ub77c \ud544\uc694\ud55c \uba74\ubd09 \ub610\ub294 \ube0c\ub7ec\uc2dc \uc720\ud615\uc744 \uba85\ud655\ud788 \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\uc6a9\ub3c4<\/th><th>\uad8c\uc7a5 \uc81c\ud488<\/th><\/tr><\/thead><tbody><tr><td>COVID-19 \/ \ud638\ud761\uae30 \uac80\uc0ac<\/td><td>\ube44\uc778\ub450 \uba74\ubd09<\/td><\/tr><tr><td>HPV\/\uc790\uad81\uacbd\ubd80 \uac80\uc0ac<\/td><td>\uc790\uad81\uacbd\ubd80 \ube0c\ub7ec\uc2dc \ubc0f \uc2a4\ud06c\ub808\uc774\ud37c<\/td><\/tr><tr><td>\ubd80\uc778\uacfc \uac80\uc0ac<\/td><td>\uc77c\ud68c\uc6a9 \uc9c8\uacbd, \uac80\uc0ac \ud0a4\ud2b8<\/td><\/tr><tr><td>\uac10\uc5fc\uc131 \uc9c8\ud658 \uc0d8\ud50c\ub9c1<\/td><td>\uba78\uade0 \uc6b4\uc1a1 \uba74\ubd09<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\ub610\ud55c \ud310\ub9e4\ud558\ub824\ub294 \uc2dc\uc7a5(\uc608: EU, US, APAC)\uc744 \uacb0\uc815\ud558\uace0 \ud544\uc694\ud55c \uc778\uc99d\uc744 \ub098\uc5f4\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>EU\uc758 \uacbd\uc6b0 MDR\uc5d0 \ub530\ub978 CE<\/li>\n\n\n\n<li>\ubbf8\uad6d\uc758 \uacbd\uc6b0 FDA 510(k) \ub610\ub294 \ubaa9\ub85d<\/li>\n\n\n\n<li>\uae00\ub85c\ubc8c \uaddc\uc815 \uc900\uc218\ub97c \uc704\ud55c ISO 13485<\/li>\n\n\n\n<li>\uc0dd\uccb4 \uc801\ud569\uc131 \ubb38\uc11c<\/li>\n\n\n\n<li>\uba78\uade0 \uac80\uc99d<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\ud83d\udcde 2\ub2e8\uacc4: \uacf5\uae09\uc5c5\uccb4\uc5d0 \uaddc\uc815 \uc900\uc218 \ud329 \uc694\uccad<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\uc7a5\uc464 \ud55c\ud5dd\uacfc \uac19\uc740 \uacf5\uae09\uc5c5\uccb4\uc5d0 \uc5f0\ub77d\ud560 \ub54c \ub2e4\uc74c\uc744 \ud3ec\ud568\ud558\ub294 \uc644\uc804\ud55c \uaddc\uc815 \uc900\uc218 \ud329\uc744 \uc694\uccad\ud558\uc2ed\uc2dc\uc624.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>CE MDR \uc778\uc99d\uc11c<\/li>\n\n\n\n<li>ISO \uc778\uc99d\uc11c<\/li>\n\n\n\n<li>\uae30\uc220 \ub370\uc774\ud130\uc2dc\ud2b8<\/li>\n\n\n\n<li>\uc0dd\uccb4 \uc801\ud569\uc131 \ud14c\uc2a4\ud2b8 \ubcf4\uace0\uc11c<\/li>\n\n\n\n<li>F. \uac00\uaca9 \ud22c\uba85\uc131 \ubc0f \ubb3c\ub958 \uc9c0\uc6d0<\/li>\n\n\n\n<li>FDA \ub4f1\ub85d \ubc88\ud638(\ud574\ub2f9\ud558\ub294 \uacbd\uc6b0)<\/li>\n\n\n\n<li>UDI \ub77c\ubca8\ub9c1 \uc0d8\ud50c<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\ud83d\udce6 3\ub2e8\uacc4: \uc0ac\uc6a9\uc790 \uc815\uc758 \uc694\uad6c \uc0ac\ud56d \ubc0f OEM \ube0c\ub79c\ub529 \ud655\uc778<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\uc790\uccb4 \ube0c\ub79c\ub4dc \ube0c\ub79c\ub4dc \ub610\ub294 OEM \ud30c\ud2b8\ub108\uc778 \uacbd\uc6b0 \ud55c\ud5dd\uc758 R&amp;D \ubc0f \ud3ec\uc7a5 \ud300\uacfc \ud611\ub825\ud558\uc5ec \ub2e4\uc74c\uc744 \uc218\ud589\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\ube0c\ub7ec\uc2dc\/\uba74\ubd09 \ub514\uc790\uc778 \uc0ac\uc6a9\uc790 \uc815\uc758<\/li>\n\n\n\n<li>\ub2e4\uad6d\uc5b4 IFU(\uc0ac\uc6a9 \uc124\uba85\uc11c) \uc778\uc1c4<\/li>\n\n\n\n<li>UDI \uc900\uc218 \uc790\uccb4 \ub77c\ubca8 \ucd94\uac00<\/li>\n\n\n\n<li>\uba78\uade0 \ud3ec\uc7a5\uacfc \ube44\uba78\uade0 \ud3ec\uc7a5 \uc911\uc5d0\uc11c \uc120\ud0dd<\/li>\n\n\n\n<li>\ub300\ub7c9 \ubc0f \uc18c\ub9e4\uc6a9 \uce74\ud1a4 \uc911\uc5d0\uc11c \uc120\ud0dd<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\ud83d\udcca 4\ub2e8\uacc4: \ud3c9\uac00\ub97c \uc704\ud55c \uc0d8\ud50c \uc8fc\ubb38<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\ub300\ub7c9 \ub3c4\ub9e4 \uc8fc\ubb38\uc744 \ud558\uae30 \uc804\uc5d0 \ud56d\uc0c1 \uc0d8\ud50c \ubc30\uce58\ub97c \ud1b5\ud574 \uc81c\ud488 \ud488\uc9c8 \ubc0f \uaddc\uc815 \uc900\uc218\ub97c \ud3c9\uac00\ud558\uc2ed\uc2dc\uc624.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\uc0d8\ud50c \uac80\ud1a0\ub97c \uc704\ud55c \uccb4\ud06c\ub9ac\uc2a4\ud2b8:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\ud3ec\uc7a5 \ubb34\uacb0\uc131 \ubc0f \ub77c\ubca8\ub9c1 \uc815\ud655\ub3c4<\/li>\n\n\n\n<li>\ube0c\ub7ec\uc2dc\/\uba74\ubd09 \uad6c\uc870 \ubc0f \uba78\uade0 \ubc00\ubd09<\/li>\n\n\n\n<li>\ubc14\ucf54\ub4dc \ubc0f UDI \ucd94\uc801\uc131<\/li>\n\n\n\n<li>IFU \uc5b8\uc5b4 \uc900\uc218<\/li>\n\n\n\n<li>\uc784\uc0c1 \uc6cc\ud06c\ud50c\ub85c\uc6b0\uc5d0 \uc801\ud569<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\ud83d\udcbc 5\ub2e8\uacc4: MOQ, \uac00\uaca9 \ubc0f \ubc30\uc1a1 \uc870\uac74 \ud611\uc0c1<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\uc8fc\ubb38\ub7c9\uc5d0 \ub530\ub978 \ub3c4\ub9e4 \uac00\uaca9\uc744 \ub17c\uc758\ud569\ub2c8\ub2e4. \ud55c\ud5dd\uc740 \uc0c8\ub85c\uc6b4 B2B \uace0\uac1d\uc744 \uc704\ud574 \ud655\uc7a5 \uac00\ub2a5\ud55c \uac00\uaca9 \uacc4\uce35\uacfc \uc720\uc5f0\ud55c MOQ\ub97c \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\ud611\uc0c1\ud574\uc57c \ud560 \uc8fc\uc694 \uc694\uc18c:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\ub2e8\uc704\ub2f9 \uac00\uaca9(\uc218\ub7c9 \uae30\uc900)<\/li>\n\n\n\n<li>\ub9ac\ub4dc \ud0c0\uc784(\uc77c\ubc18\uc801\uc73c\ub85c 2\u20134\uc8fc)<\/li>\n\n\n\n<li>Incoterms(FOB, CIF, DDP)<\/li>\n\n\n\n<li>\uc6b4\uc1a1 \uc635\uc158(\ud56d\uacf5, \ud574\uc0c1, \ud0dd\ubc30)<\/li>\n\n\n\n<li>\uacb0\uc81c \uc870\uac74(T\/T, LC)<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\ud83d\udccb 6\ub2e8\uacc4: \uaddc\uc81c \ud30c\uc77c\ub9c1 \ucd5c\uc885 \uc644\ub8cc(\ud544\uc694\ud55c \uacbd\uc6b0)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">EU \ub610\ub294 \ubbf8\uad6d \uc2dc\uc7a5\uc758 \uacbd\uc6b0 \ucd94\uac00 \ub2e8\uacc4\uac00 \ud3ec\ud568\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>EUDAMED\uc5d0 \uc81c\ud488 \ud30c\uc77c\ub9c1(EU)<\/li>\n\n\n\n<li>FDA\uc5d0 \uc7a5\uce58 \ubaa9\ub85d(\ubbf8\uad6d)<\/li>\n\n\n\n<li>510(k) \uc81c\ucd9c(\uc7a5\uce58 \ud074\ub798\uc2a4\uc5d0\uc11c \uc694\uad6c\ud558\ub294 \uacbd\uc6b0)<\/li>\n\n\n\n<li>\uac01 \uad6d\uac00\uc5d0 \ub300\ud55c \ud604\uc9c0 \uc5b8\uc5b4 IFU \ubcf4\uc7a5<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\ud83d\udce6 7\ub2e8\uacc4: \ubc30\uc1a1 \ubc0f \ubc30\uc1a1 \ud6c4 \uaddc\uc815 \uc900\uc218 \ud655\uc778 \uc900\ube44<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\ubc30\uc1a1 \uc804\uc5d0 \ud55c\ud5dd\uc740 \ub2e4\uc74c\uc744 \uc218\ud589\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\ucd5c\uc885 QC \uac80\uc0ac \uc2e4\uc2dc<\/li>\n\n\n\n<li>UDI \ub77c\ubca8 \ubc0f \ubc30\uce58 \ucf54\ub4dc \uc801\uc6a9<\/li>\n\n\n\n<li>\uace0\uac1d \uc0ac\uc591\uc5d0 \ub530\ub77c \ud3ec\uc7a5<\/li>\n\n\n\n<li>\ubc30\uc1a1 \ubb38\uc11c \uc81c\uacf5(\uc1a1\uc7a5, \ud3ec\uc7a5 \ubaa9\ub85d, COA)<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\ubc30\uc1a1 \ud6c4 \ucd5c\uc885 \uaddc\uc815 \uc900\uc218 \uac10\uc0ac\ub97c \uc218\ud589\ud558\uc5ec \ub2e4\uc74c\uc744 \ud655\uc778\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>COA \ubc0f \ub77c\ubca8\ub9c1\uc774 \uc8fc\ubb38\uacfc \uc77c\uce58<\/li>\n\n\n\n<li>\ud3ec\uc7a5 \uc0c1\ud0dc\ub294 \uc628\uc804\ud558\uba70 \uba78\uade0 \ucc98\ub9ac\ub418\uc5c8\uc2b5\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\ucd94\uc801\uc131 \ubb38\uc11c\ub294 \ubcf4\uad00\ub429\ub2c8\ub2e4.<\/li>\n<\/ul>\n\n\n\n<ol start=\"9\" class=\"wp-block-list\">\n<li>FAQ: 2025\ub144 \uc758\ub8cc\uc6a9 \uba74\ubd09 \uaddc\uc81c\uc5d0 \ub300\ud574 B2B \uad6c\ub9e4\uc790\uac00 \uc54c\uc544\uc57c \ud560 \ubaa8\ub4e0 \uac83<\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">Q1: \ubaa8\ub4e0 \uc758\ub8cc\uc6a9 \uba74\ubd09\uacfc \ube0c\ub7ec\uc2dc\ub294 \uc774\uc81c EU\uc5d0\uc11c MDR \uaddc\uc81c\ub97c \ubc1b\uc2b5\ub2c8\uae4c?<br>\uc608. 2025\ub144\ubd80\ud130 \uba74\ubd09 \ubc0f \ube0c\ub7ec\uc2dc\uc640 \uac19\uc740 Class I \uc758\ub8cc\uae30\uae30\ub294 CE \uc778\uc99d, GSPR, PMS \uc758\ubb34\ub97c \ud3ec\ud568\ud558\uc5ec MDR(\uc758\ub8cc\uae30\uae30 \uaddc\uc815 2017\/745)\uc744 \uc644\uc804\ud788 \uc900\uc218\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Q2: UDI\ub780 \ubb34\uc5c7\uc774\uba70 \uc720\ud1b5\uc5c5\uccb4\uc5d0\uac8c \uc65c \uc911\uc694\ud569\ub2c8\uae4c?<br>UDI(Unique Device Identifier, \uace0\uc720 \uc7a5\uce58 \uc2dd\ubcc4\uc790)\ub294 FDA\uc640 MDR \ubaa8\ub450\uc5d0\uc11c \uc694\uad6c\ud558\ub294 \ucd94\uc801\uc131 \uc694\uac74\uc785\ub2c8\ub2e4. \uac10\uc2dc, \ub9ac\ucf5c, \uc2dc\ud310 \ud6c4 \uac10\uc2dc \uacfc\uc815\uc5d0\uc11c \uc7a5\uce58\ub97c \uc2dd\ubcc4\ud558\ub294 \ub370 \ub3c4\uc6c0\uc774 \ub429\ub2c8\ub2e4. \uc720\ud1b5\uc5c5\uccb4\ub294 UDI\uac00 \uc874\uc7ac\ud558\uace0 \uc62c\ubc14\ub974\uac8c \ub77c\ubca8\ub9c1\ub418\uc5c8\ub294\uc9c0 \ud655\uc778\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Q3: CE \ub9c8\ud06c\uac00 \uc5c6\ub294 \uba74\ubd09\uc744 \uc720\ub7fd\uc73c\ub85c \uc218\uc785\ud560 \uc218 \uc788\uc2b5\ub2c8\uae4c?<br>\uc544\ub2c8\uc694. 2025\ub144\ubd80\ud130 \uae30\uc874 MDD \uc778\uc99d\uc11c\ub294 \ub354 \uc774\uc0c1 \uc720\ud6a8\ud558\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. \ubaa8\ub4e0 \uc218\uc785\ud488\uc740 \uae30\uc220 \ubb38\uc11c\ub97c \ud3ec\ud568\ud55c MDR CE \uc778\uc99d\uc744 \ubc1b\uc544\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Q4: \uc7a5\uc464\ud55c\ud5dd\uc740 OEM \ube0c\ub79c\ub529\uc744 \uc5b4\ub5bb\uac8c \uc9c0\uc6d0\ud560 \uc218 \uc788\uc2b5\ub2c8\uae4c?<br>\ud55c\ud5dd\uc740 \ub9de\ucda4\ud615 \uba74\ubd09\/\ube0c\ub7ec\uc2dc \ub514\uc790\uc778, \ub2e4\uad6d\uc5b4 \ud3ec\uc7a5, UDI \ub77c\ubca8\ub9c1, \uc790\uccb4 \ube0c\ub79c\ub4dc \ube0c\ub79c\ub529\uc744 \ud3ec\ud568\ud55c \ud3ec\uad04\uc801\uc778 OEM \uc11c\ube44\uc2a4\ub97c \uc81c\uacf5\ud558\uba70, \ubaa8\ub4e0 \uaddc\uc81c \uc9c0\uc6d0\uc744 \uc644\ubcbd\ud558\uac8c \uc81c\uacf5\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Q5: 2025\ub144\uc5d0 \uc81c\uc870\uc5c5\uccb4\uc5d0 \uc5b4\ub5a4 \uc778\uc99d\uc744 \uc694\uccad\ud574\uc57c \ud569\ub2c8\uae4c?<br>ISO 13485, ISO 9001, MDR CE \uc778\uc99d\uc11c, FDA \ub4f1\ub85d \ub610\ub294 510(k), \uc0dd\uccb4 \uc801\ud569\uc131 \ud14c\uc2a4\ud2b8 \uacb0\uacfc \ubc0f \uba78\uade0 \uc720\ud6a8\uc131 \uac80\uc0ac \ubcf4\uace0\uc11c\ub97c \uc694\uccad\ud558\uc2ed\uc2dc\uc624.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Q6: \ud55c\ud5dd\uc758 \ub3c4\ub9e4 \uc8fc\ubb38\uc5d0 \ub300\ud55c \uc77c\ubc18\uc801\uc778 MOQ\ub294 \uc5bc\ub9c8\uc785\ub2c8\uae4c?<br>MOQ\ub294 \uc720\uc5f0\ud558\uba70 \uc81c\ud488 \uc720\ud615 \ubc0f \uad6c\ub9e4\uc790 \uc694\uad6c \uc0ac\ud56d\uc5d0 \ub530\ub77c \uc870\uc815\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ub300\ubd80\ubd84\uc758 \ucd08\uae30 \uc8fc\ubb38\uc740 5,000~10,000\uac1c\ubd80\ud130 \uc2dc\uc791\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Q7: \ub3c4\ub9e4 \uc8fc\ubb38\uc744 \ubc1b\uc73c\ub824\uba74 \uc5bc\ub9c8\ub098 \uac78\ub9bd\ub2c8\uae4c?<br>\ud45c\uc900 \ub9ac\ub4dc \ud0c0\uc784\uc740 \uc8fc\ubb38 \ud655\uc778 \ud6c4 2~4\uc8fc\uc785\ub2c8\ub2e4. OEM\/\ub9de\ucda4\ud615 \uc8fc\ubb38\uc758 \uacbd\uc6b0 \ub514\uc790\uc778 \ubc0f \uc2b9\uc778\uc5d0 1~2\uc8fc\uac00 \ub354 \ud544\uc694\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Q8: \uac00\uaca9 \ubc0f \uc0d8\ud50c\uc5d0 \ub300\ud55c \ud55c\ud5dd\uc5d0 \uc5b4\ub5bb\uac8c \uc5f0\ub77d\ud569\ub2c8\uae4c?<br>\ud55c\ud5dd \uacf5\uc2dd \uc6f9\uc0ac\uc774\ud2b8\ub97c \ud1b5\ud574 \uc5f0\ub77d\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. <a href=\"https:\/\/hanheng-medical.com\/ko\/\" target=\"_blank\" rel=\"noreferrer noopener\">www.hanheng-medical.com<\/a> \ub610\ub294 \ud83d\udce9\ub85c \uc774\uba54\uc77c\uc744 \ubcf4\ub0b4\uc8fc\uc138\uc694. <a href=\"mailto:sales@hanhengmed.com\" target=\"_blank\" rel=\"noreferrer noopener\">sales@hanhengmed.com<\/a>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\ud83d\udce3 \ucd5c\uc885 \uc870\uce58:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">B2B \uad6c\ub9e4\uc790\uc758 \uacbd\uc6b0 \uaddc\uc815 \uc900\uc218\ub294 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rel=\"noreferrer noopener\">www.hanheng-medical.com<\/a><br>\u2705 \uacac\uc801 \ub610\ub294 \uc0c1\ub2f4 \uc694\uccad: \ud83d\udce9 <a href=\"mailto:sales@hanhengmed.com\" target=\"_blank\" rel=\"noreferrer noopener\">sales@hanhengmed.com<\/a><br>\u2705 \uc778\uc99d\ub41c \uc6b0\uc218\uc131\uc73c\ub85c \uacf5\uae09\ub9dd\uc744 \ud655\ubcf4\ud558\uc2ed\uc2dc\uc624.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\uaddc\uc815\uc744 \uc900\uc218\ud558\uc2ed\uc2dc\uc624. \uc55e\uc11c \ub098\uac00\uc2ed\uc2dc\uc624. \ud55c\ud5dd\uc744 \uc120\ud0dd\ud558\uc2ed\uc2dc\uc624.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>2025\ub144\uc5d0 \uac00\uae4c\uc6cc\uc9c0\uba74\uc11c \uc758\ub8cc \uc18c\ubaa8\ud488\uc5d0 \ub300\ud55c \uc804 \uc138\uacc4\uc801\uc778 \uc0c1\ud669\uc774 \uc0c1\ub2f9\ud55c \ubcc0\ud654\ub97c \uacaa\uace0 \uc788\uc2b5\ub2c8\ub2e4. \uac00\uc7a5 \ud070 \uc601\ud5a5\uc744 \ubc1b\ub294 \uc81c\ud488 \ubc94\uc8fc \uc911\uc5d0\ub294 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