Medical Device Division · registration 180052ActiveThoratec
Hong KongCirculatory Assist Units, Cardiac, VentricularClass IVThoratec Corporation
Official record identity
- MDACS listing number
- 180052
- Model name
- HeartMate 3 Left Ventricular Assist System (106524INT, 10001696INT, 105581INT, 106522INT, 106533INT, 1050, 106532INT, 106528INT, 106534INT, 10002222INT, 106526INT, 106531INT, 106525INT, 1286INT, 106128, 101609, 107758, 107757, 103868, 103426, 103869, 2465, 2865, 109200, 103859, 103861, 1260, 104232, 106129, 104229, 104230, 104231, 104234, 104233, 106449)
- Registration date
- March 07, 2023
- Expiry date
- March 07, 2028
- Source update date
- September 05, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
Official value: IV
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
- Revision number
- a
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.