Pure Global
180248
IV
current

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

This profile provides complete Hong Kong MDACS registration information for Catheters, Vascular, Angioplasty, Balloon, Coronary, Perfusion. 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, Perfusion

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

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
17521
Product Code Detail
17521 Catheters, Vascular, Angioplasty, Balloon, Coronary, Perfusion
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
SIS Medical AG
SIS Medical AG
Switzerland
็‘žๅฃซ
Hungerbuelstrasse 12a, 8500 Frauenfeld, Switzerland
Hungerbuelstrasse 12a, 8500 Frauenfeld, ็‘žๅฃซ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
August 08, 2024
Expiry Date
August 06, 2028
Product Models
OPN NC (150-010-004, 150-015-004, 150-020-004, 200-010-004, 200-015-004, 200-020-004, 250-010-004, 250-015-004, 250-020-004, 300-010-004, 300-015-004, 300-020-004, 350-010-004, 350-015-004, 350-020-004, 400-010-004, 400-015-004, 400-020-004, 450-010-004, 450-015-004, 450-020-004)
OPN NC(150-010-004ใ€150-015-004ใ€150-020-004ใ€200-010-004ใ€200-015-004ใ€200-020-004ใ€250-010-004ใ€250-015-004ใ€250-020-004ใ€300-010-004ใ€300-015-004, 300-020-004, 350-010-004, 350-015-004, 350-020-004, 400-010-004, 400-015-004, 400-020-004, 450-010-004, 450-015-004, 450-020-004)