Pure Global
150048
IV
Expired.

Prostheses, Cardiac Valveๅ‡ไฝ“ใ€ๅฟƒ่„็“ฃ่†œ

This profile provides complete Hong Kong MDACS registration information for Prostheses, Cardiac Valve. 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: Prostheses, Cardiac Valve

็”ขๅ“่ณ‡่จŠ๏ผš ๅ‡ไฝ“ใ€ๅฟƒ่„็“ฃ่†œ

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
13138
Product Code Detail
13138 Prostheses, Cardiac Valve
State
Expired.
Status
N/A
Pure Global
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Manufacturer (่ฃฝ้€ ๅ•†)
Sorin Group Canada Inc, Mitroflow Division
Sorin Group Canada Inc, Mitroflow Division
Canada
ๅŠ ๆ‹ฟๅคง
5005 North Fraser Way, Burnaby, British Columbia, V5J 5M1, Canada
5005 North Fraser Way, ๆœฌๆ‹ฟๆฏ”, ไธๅˆ—้ข ๅ“ฅไผฆๆฏ”ไบš็œ, V5J 5M1, ๅŠ ๆ‹ฟๅคง
Authorised Representative (AR)
IN-MEDI Company Limited
็ ”่ฟชๆœ‰้™ๅ…ฌๅธ
35273026
Regulatory Timeline
Registration Date
April 23, 2015
Expiry Date
April 23, 2020
Product Models
Mitroflow Aortic Pericardial Heart Valve (LXA19, LXA21, LXA23, LXA25, LXA27, LXA29, DLA19, DLA21, DLA23, DLA25, DLA27, DLA29)
ไบŒ็บฟๆตไธปๅŠจ่„‰ๅฟƒๅŒ…ๅฟƒ่„็“ฃ่†œ(LXA19ใ€LXA21ใ€LXA23ใ€LXA25ใ€LXA27ใ€LXA29ใ€DLA19ใ€DLA21ใ€DLA23ใ€DLA25ใ€DLA27ใ€DLA29)