130427
IV
Expired.
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This profile provides complete Hong Kong MDACS registration information for Circulatory Assist Units, Cardiac, Ventricular. 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: Circulatory Assist Units, Cardiac, Ventricular
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
10847
Product Code Detail
10847 Circulatory Assist Units, Cardiac, Ventricular
State
Expired.
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
HeartWare, Inc.
HeartWare, Inc.
United States
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14400 NW 60th Avenue, Miami Lakes, Florida, 33014, USA
14400 NW 60th Avenue, ่ฟ้ฟๅฏๆนๅบ, ไฝ็ฝ้่พพๅท, 33014, ็พๅฝ
Authorised Representative (AR)
IntegMed Limited
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ฌๅธ
35273026
Regulatory Timeline
Registration Date
August 05, 2015
Expiry Date
November 21, 2018
Product Models
Ventricular Assist System
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