180052
Circulatory Assist Units, Cardiac, Ventricular
循环辅助单元,心脏,心室
Thoratec Corporation·IV·Hong Kong MDACS·Registered March 07, 2023
Device overview
- Risk class
- IV
- Product code
- 10847
- State
- current
- Status
- N/A
- Product code detail
- 10847 Circulatory Assist Units, Cardiac, Ventricular
Manufacturer (製造商)
- Name
- Thoratec CorporationThoratec Corporation
- Country
- United States美国
- Address
- 6035 Stoneridge Drive, Pleasanton, California, 94588, USA6035 Stoneridge Drive, 普莱森顿, 加利福尼亚州, 94588, 美国
Authorised representative (AR)
- Phone
- 21074668
Regulatory timeline
- Registration date
- March 07, 2023
- Expiry date
- March 07, 2028
Product models
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)
HeartMate 3 左心室辅助系统 (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)
About this record
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
產品資訊: 循环辅助单元,心脏,心室