Pure Global
240273
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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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Medtronic CoreValve LLC
Medtronic CoreValve LLC
United States
็พŽๅ›ฝ
1851 E. Deere Ave, Santa Ana, CA 92705, USA
1851 E.่ฟชๅฐ”ๅคง้“,ๅœฃๅฎ‰ๅจœ,CA 92705,็พŽๅ›ฝ
Authorised Representative (AR)
29191300
Regulatory Timeline
Registration Date
July 23, 2024
Expiry Date
July 22, 2029
Product Models
Evolut FX System (EVOLUTFX-23, EVOLUTFX-26, EVOLUTFX-29, EVOLUTFX-34, D-EVOLUTFX-2329, D-EVOLUTFX-34, L-EVOLUTFX-2329, L-EVOLUTFX-34)
Evolut FX ็ณป็ปŸ (EVOLUTFX-23, EVOLUTFX-26, EVOLUTFX-29, EVOLUTFX-34, D-EVOLUTFX-2329, D-EVOLUTFX-34, L-EVOLUTFX-2329, L-EVOLUTFX-34)