Pure Global
220151
IV
current

Prostheses, Cardiac Valve, Biologicalๅ‡ไฝ“, ๅฟƒ่„็“ฃ่†œ, ็”Ÿ็‰ฉ

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

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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
15870
Product Code Detail
15870 Prostheses, Cardiac Valve, Biological
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Edwards Lifesciences LLC
Edwards Lifesciences
United States
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One Edwards Way, Irvine, CA 92614, USA
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Authorised Representative (AR)
31809428/36192691
Regulatory Timeline
Registration Date
August 29, 2023
Expiry Date
May 16, 2027
Product Models
MITRIS RESILIA Mitral Valve 11400M (11400M25, 11400M27, 11400M29, 11400M31, 11400M33)
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