100551
IV
current
Circulatory Assist Units, Cardiac, Ventricularๅพช็ฏ่พ ๅฉๅๅ ,ๅฟ่,ๅฟๅฎค
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
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Thoratec Corporation
Thoratec Corporation
United States
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6035 Stoneridge Drive, Pleasanton, California 94588, USA
6035 Stoneridge Drive, ๆฎ่ฑๆฃฎ้กฟ, ๅ ๅฉ็ฆๅฐผไบๅท 94588, ็พๅฝ
Authorised Representative (AR)
21074668
Regulatory Timeline
Registration Date
January 05, 2021
Expiry Date
February 14, 2026
Product Models
HeartMate II Left Ventricular Assist System (103695, 104911, 102564, 104142, 102563, 102781, 103393, 104692, 107315, 103696, 1286, 1280N, 2020VE, 102137, 102772, 102138, 1050, 1264, 1065, 100760, 100759, 101609, 1340, 103426, 1440, 2465, 2865, 103871, 103859, 103860, 2230, 104216, 104222, 104223, 104224, 104225, 104226, 104227, 104228, 106015, 106762, 106128, 107754, 107760, 105557, 105558, 103479, 1260, 104232, 106129, 104229, 104230, 104231, 104234, 104233, 106449)
HeartMate II ๅทฆๅฟๅฎค่พ
ๅฉ็ณป็ป (103695, 104911, 102564, 104142, 102563, 102781, 103393, 104692, 107315, 103696, 1286, 1280N, 2020VE, 102137, 102772, 102138, 1050, 1264, 1065, 100760, 100759, 101609, 1340, 103426 104216, 1440, 2465, 2865, 103871, 103859, 103860, 2230, , 104222, 104223, 104224, 104225, 104226, 104227, 104228, 106015, 106762, 106128, 107754, 107760, 105557, 105558, 103479, 1260, 104232, 106129, 104229, 104230, 104231, 104234, 104233, 106449)