230426
IV
current
Prostheses, Cardiac Valve, Biological, Tissue Leafletๅไฝใๅฟ่็ฃ่ใ็็ฉใ็ป็ปไผ ๅ
This profile provides complete Hong Kong MDACS registration information for Prostheses, Cardiac Valve, Biological, Tissue Leaflet. 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, Tissue Leaflet
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
33935
Product Code Detail
33935 Prostheses, Cardiac Valve, Biological, Tissue Leaflet
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
P+F Products + Features GmbH
P+F Products + Features GmbH
Germany
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Argelsrieder Feld 1a, 82234 Wessling, Germany
Argelsrieder Feld 1a, 82234 Wessling, ๅพทๅฝ
Authorised Representative (AR)
OrbusNeich Medical Company Limited
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ฌๅธ
31097271/31097216
Regulatory Timeline
Registration Date
November 15, 2023
Expiry Date
November 15, 2028
Product Models
TricValve Transcatheter Bicaval Valves System (SVC 25, SVC 29, IVC 31, IVC 35)
TricValve ็ปๅฏผ็ฎกๅ่
็ฃ่็ณป็ป(SVC 25ใSVC 29ใIVC 31ใIVC 35)