Medical Device Division · registration 100551Expired

Thoratec

Name: Thoratec — Medical Device Division 100551
Creator: Thoratec Corporation
Keywords: Thoratec, Thoratec, 100551, Circulatory Assist Units, Cardiac, Ventricular, Medical Device Division

Hong KongCirculatory Assist Units, Cardiac, VentricularClass IVThoratec Corporation

Verified

Official record identity

MDACS listing number: 100551
Model name: 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)
Registration date: January 05, 2021
Expiry date: February 14, 2026
Source update date: February 27, 2024
Status: Expired

Classification

Risk class: Class IV
Published category: Circulatory Assist Units, Cardiac, Ventricular

Published parties

Registrant / registration holder: Transmedic China Limited
Manufacturer: Thoratec Corporation

Official description

Circulatory Assist Units, Cardiac, Ventricular

Additional source fields

AMD nomenclature code: 10847
Traditional Chinese local responsible person: 傳新中國有限公司
Local responsible person phone: 21074668
Published manufacturer address: 6035 Stoneridge Drive, Pleasanton, California 94588, USA
Published remarks: Expired.
Revision number: c

About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.