Pure Global
80145
IV
Expired.

Catheters, Vascular, Angioplasty, Balloonๅฏผ็ฎกใ€่ก€็ฎกใ€่ก€็ฎกๆˆๅฝขๆœฏใ€็ƒๅ›Š

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

็”ขๅ“่ณ‡่จŠ๏ผš ๅฏผ็ฎกใ€่ก€็ฎกใ€่ก€็ฎกๆˆๅฝขๆœฏใ€็ƒๅ›Š

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
17184
Product Code Detail
17184 Catheters, Vascular, Angioplasty, Balloon
State
Expired.
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
OrbusNeich Medical B.V.
Orbusneich Medical, B.V.
Netherlands
่ทๅ…ฐ
Drs. W. van Royenstraat 5, 3871 AN Hoevelaken, The Netherlands
Drs. W. van Royenstraat 5, 3871 AN Hoevelaken, ่ทๅ…ฐ
Authorised Representative (AR)
OrbusNeich Medical Company Limited
ไธš่šๅŒป็–—ๆœ‰้™ๅ…ฌๅธ
31097271/31097216
Regulatory Timeline
Registration Date
June 11, 2018
Expiry Date
August 19, 2023
Product Models
Sapphire NC Coronary Dilatation Catheter (220-083-2, 220-103-2, 220-123-2, 220-153-2, 220-183-2, 222-083-2, 222-103-2, 222-123-2, 222-153-2, 222-183-2, 225-083-2, 225-103-2, 225-123-2, 225-153-2, 225-183-2, 227-083-2, 227-103-2, 227-123-2, 227-153-2, 227-183-2, 230-083-2, 230-103-2, 230-123-2, 230-153-2, 230-183-2, 232-083-2, 232-103-2, 232-123-2, 232-153-2, 232-183-2, 235-083-2, 235-103-2, 235-123-2, 235-153-2, 235-183-2, 237-083-2, 237-103-2, 237-123-2, 237-153-2, 237-183-2, 240-083-2, 240-103-2, 240-123-2, 240-153-2, 240-183-2, 245-083-2, 245-103-2, 245-123-2, 245-153-2, 245-183-2, 250-083-2, 250-103-2, 250-123-2, 250-153-2, 250-183-2)
่“ๅฎ็ŸณNCๅ† ็ŠถๅŠจ่„‰ๆ‰ฉๅผ ๅฏผ็ฎก(220-083-2,220-103-2,220-123-2,220-153-2,220-183-2,222-083-2,222-103-2,222-123-2,222-153-2,222-183-2,225-083-2,225-103-2,225-123-2,225-153-2,225-183-2,227-083-2,227-103-2,227-123-2,227-153-2,227-183-2, 230-083-2, 230-103-2, 230-123-2, 230-153-2, 230-183-2, 232-083-2, 232-103-2, 232-123-2, 232-153-2, 232-183-2, 235-083-2, 235-103-2, 235-123-2, 235-153-2, 235-183-2, 237-083-2, 237-103-2, 237-123-2, 237-153-2, 237-183-2, 240-083-2, 240-103-2, 240-123-2, 240-153-2, 240-183-2, 245-083-2, 245-103-2, 245-123-2, 245-153-2, 245-183-2, 250-083-2, 250-103-2, 250-123-2, 250-153-2, 250-183-2)