150220
IV
Delisted
Prostheses, Cardiac Valveๅฟ่็ฃ่ๅไฝ
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
State
N/A
Status
Delisted
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Manufacturer (่ฃฝ้ ๅ)
Medtronic CoreValve LLC
Medtronic CoreValve LLC
United States
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1851 E. Deere Ave, Santa Ana, CA 92705, USA
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Authorised Representative (AR)
Regulatory Timeline
Registration Date
January 23, 2020
Expiry Date
July 16, 2025
Delist Date
August 30, 2023
Remarks
Delisted.
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Product Models
CoreValve Evolut R System (EVOLUTR-23, EVOLUTR-26, EVOLUTR-29, EVOLUTR-34, ENVEOR-L, ENVEOR-N, LS-ENVEOR-23, LS-ENVEOR-34, LS-ENVEOR-2629), CoreValve Evolut PRO System (EVOLUTPRO-23, EVOLUTPRO-26, EVOLUTPRO-29, LS-MDT2-23, LS-MDT2-2629)