Pure Global
240092
IV
current

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

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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
13138
Product Code Detail
13138 Prostheses, Cardiac Valve
State
current
Status
N/A
Pure Global
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Manufacturer (่ฃฝ้€ ๅ•†)
Abbott Vascular
Abbott Vascular
United States
็พŽๅ›ฝ
3200 Lakeside Drive, Santa Clara, California, 95054, USA
3200ๆน–ๆปจๅคง้“, ๅœฃๅ…‹ๆ‹‰ๆ‹‰, ๅŠ ๅˆฉ็ฆๅฐผไบšๅทž, 95054, ็พŽๅ›ฝ
Authorised Representative (AR)
Abbott Medical (Hong Kong) Limited
็พŽๅ›ฝ้›…ๅŸนๅŒป็–—็”จๅ“(้ฆ™ๆธฏ)ๆœ‰้™ๅ…ฌๅธ
29967688
Regulatory Timeline
Registration Date
April 03, 2024
Expiry Date
April 02, 2029
Product Models
MitraClip G4 System Delivery System (CDS0705-NT, CDS0705-XT, CDS0705-NTW, CDS0705-XTW), MitraClip G4 Steerable Guide Catheter (SGC0705)
MitraClip G4 ็ณป็ปŸ่พ“้€็ณป็ปŸ(CDS0705-NTใ€CDS0705-XTใ€CDS0705-NTWใ€CDS0705-XTW)ใ€MitraClip G4 ๅฏๆ“็บตๅฏผ็ฎก (SGC0705)