Pure Global
180108
IV
Expired.

Catheters, Vascular, Angioplasty, Balloon, Coronaryๅฏผ็ฎกใ€่ก€็ฎกใ€่ก€็ฎกๆˆๅฝขๆœฏใ€็ƒๅ›Šใ€ๅ† ็ŠถๅŠจ่„‰

This profile provides complete Hong Kong MDACS registration information for Catheters, Vascular, Angioplasty, Balloon, Coronary. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.

Product Info: Catheters, Vascular, Angioplasty, Balloon, Coronary

็”ขๅ“่ณ‡่จŠ๏ผš ๅฏผ็ฎกใ€่ก€็ฎกใ€่ก€็ฎกๆˆๅฝขๆœฏใ€็ƒๅ›Šใ€ๅ† ็ŠถๅŠจ่„‰

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
34313
Product Code Detail
34313 Catheters, Vascular, Angioplasty, Balloon, Coronary
State
Expired.
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Genoss Co., Ltd.
Genoss Co., Ltd.
South Korea
้Ÿฉๅ›ฝ
1F, Gyeonggi R&DB Center/226, 2F, GSBC, 105 Gwanggyo-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea
ไบฌ็•ฟ้“ไบฌ็•ฟ้“ๆฐธ้€šๅŒบๅ…‰ๆกฅ่ทฏ105ๅทGSBC2ๆฅผ1ๆฅผ,ไบฌ็•ฟ้“R&DBไธญๅฟƒ/226ๆฅผ
Authorised Representative (AR)
Angeion Medical HK Limited
ๅฎ‰ๅฅๅŒป็–—้ฆ™ๆธฏๆœ‰้™ๅ…ฌๅธ
96886105
Regulatory Timeline
Registration Date
May 04, 2018
Expiry Date
May 04, 2023
Product Models
NC Genoss PTCA Balloon Catheter (GHBC-08-200, GHBC-08-225, GHBC-08-250, GHBC-08-275, GHBC-08-300, GHBC-08-325, GHBC-08-350, GHBC-08-375, GHBC-08-400, GHBC-08-425, GHBC-08-450, GHBC-08-475 GHBC-08-500, GHBC-10-200, GHBC-10-225, GHBC-10-250, GHBC-10-275, GHBC-10-300, GHBC-10-325, GHBC-10-350, GHBC-10-375, GHBC-10-400, GHBC-10-425, GHBC-10-450, GHBC-10-475, GHBC-10-500, GHBC-12-200, GHBC-12-225, GHBC-12-250, GHBC-12-275, GHBC-12-300, GHBC-12-325, GHBC-12-350, GHBC-12-375, GHBC-12-400, GHBC-12-425, GHBC-12-450, GHBC-12-475, GHBC-12-500, GHBC-16-200, GHBC-16-225, GHBC-16-250, GHBC-16-275, GHBC-16-300, GHBC-16-325, GHBC-16-350, GHBC-16-375, GHBC-16-400, GHBC-20-200, GHBC-20-225, GHBC-20-250, GHBC-20-275, GHBC-20-300, GHBC-20-325, GHBC-20-350, GHBC-20-375, GHBC-20-400, GPHBC-08-200, GPHBC-08-225, GPHBC-08-250, GPHBC-08-275, GPHBC-08-300, GPHBC-08-325, GPHBC-08-350, GPHBC-08-375, GPHBC-08-400, GPHBC-08-425, GPHBC-08-450, GPHBC-08-475, GPHBC-08-500, GPHBC-10-200, GPHBC-10-225, GPHBC-10-250, GPHBC-10-275, GPHBC-10-300, GPHBC-10-325, GPHBC-10-350, GPHBC-10-375, GPHBC-10-400, GPHBC-10-425, GPHBC-10-450, GPHBC-10-475, GPHBC-10-500, GPHBC-12-200, GPHBC-12-225, GPHBC-12-250, GPHBC-12-275, GPHBC-12-300, GPHBC-12-325, GPHBC-12-350, GPHBC-12-375, GPHBC-12-400, GPHBC-12-425, GPHBC-12-450, GPHBC-12-475, GPHBC-12-500, GPHBC-16-200, GPHBC-16-225, GPHBC-16-250, GPHBC-16-275, GPHBC-16-300, GPHBC-16-325, GPHBC-16-350, GPHBC-16-375, GPHBC-16-400, GPHBC-20-200, GPHBC-20-225, GPHBC-20-250, GPHBC-20-275, GPHBC-20-300, GPHBC-20-325, GPHBC-20-350, GPHBC-20-375, GPHBC-20-400)
NC Genoss PTCA ็ƒๅ›Šๅฏผ็ฎก (GHBC-08-200, GHBC-08-225, GHBC-08-250, GHBC-08-275, GHBC-08-300, GHBC-08-325, GHBC-08-350, GHBC-08-375, GHBC-08-400, GHBC-08-425, GHBC-08-450, GHBC-08-475, GHBC-08-500, GHBC-10-200, GHBC-10-225, GHBC-10-250, GHBC-10-250, GHBC-10-2777 5, GHBC-10-300, GHBC-10-325, GHBC-10-350, GHBC-10-375, GHBC-10-400, GHBC-10-425, GHBC-10-450, GHBC-10-475, GHBC-10-500, GHBC-12-200, GHBC-12-225, GHBC-12-250, GHBC-12-275, GHBC-12-300, GHBC-12-325, GHBC-12-350, GHBC-12-375, GHBC-12-400,GHBC-12-425, GHBC-12-450, GHBC-12-475, GHBC-12-500, GHBC-16-200, GHBC-16-225, GHBC-16-250, GHBC-16-275, GHBC-16-300, GHBC-16-325, GHBC-16-350, GHBC-16-375, GHBC-16-400, GHBC-20-200, GHBC-20-225, GHBC-20-250, GHBC-20-275, GHBC-20-300, GHBC-20-3222 5, GHBC-20-350, GHBC-20-375, GHBC-20-400, GPHBC-08-200, GPHBC-08-225, GPHBC-08-250, GPHBC-08-275, GPHBC-08-300, GPHBC-08-325, GPHBC-08-350, GPHBC-08-375, GPHBC-08-400, GPHBC-08-425, GPHBC-08-450, GPHBC-08-475, GPHBC-08-500, GPHBC-10-200,GPHBC-10-225, GPHBC-10-250, GPHBC-10-275, GPHBC-10-300, GPHBC-10-325, GPHBC-10-350, GPHBC-10-375, GPHBC-10-400, GPHBC-10-425, GPHBC-10-450, GPHBC-10-475, GPHBC-10-500, GPHBC-12-200, GPHBC-12-225, GPHBC-12-250, GPHBC-12-275, GPHBC-12-300, GPHBC-12-12 -300 hbc-12-325, GPHBC-12-350, GPHBC-12-375, GPHBC-12-400, GPHBC-12-425, GPHBC-12-450, GPHBC-12-475, GPHBC-12-500, GPHBC-16-200, GPHBC-16-225, GPHBC-16-250, GPHBC-16-275, GPHBC-16-300, GPHBC-16-325, GPHBC-16-350, GPHBC-16-375, GPHBC-16-400,GPHBC-20-200, GPHBC-20-225, GPHBC-20-250, GPHBC-20-275, GPHBC-20-300, GPHBC-20-325, GPHBC-20-350, GPHBC-20-375, GPHBC-20-400)