180212
Circulatory Assist Units, Cardiac, Ventricular
循环辅助单元,心脏,心室
Berlin Heart GmbH·IV·Hong Kong MDACS·Registered March 03, 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
- Berlin Heart GmbHBerlin Heart GmbH
- Address
- Wiesenweg 10, 12247 Berlin, GERMANYWiesenweg 10, 12247 柏林, 德国
Authorised representative (AR)
- Name
- IN-MEDI Company Limited研迪有限公司
- Phone
- 35273026
Regulatory timeline
- Registration date
- March 03, 2023
- Expiry date
- July 11, 2028
Product models
Ventricular Assist Device EXCOR VAD System (D03I-001, 1600190, 1600422, P10P-001, P15P-001, P25P-001x01, P30P-001x01, P50P-001, P60P-001, P80P-001, P50C-001, P60C-001, P80C-001, P80C-005, C60G-002, C60G-002m, C85G-002, C85G-002m, C60G-004, C60G-004m, C85G-004, C85G-004m, C80G-021, C80G-021m, C80G-040m, C00P-001, C00P-004, C22V-002, C22V-002m, C22V-004, C25V-004, C26V-002, C26V-002m, C23V-004m, C15V-040m, C19V-020, C19V-020m, C14A-040m, C18A-020, C22A-004, C27A-001, A06-009, A09-012, A06-006, A09-009, A12-012, T00L-002, L20H-002x01, L20H-003x01), Mobile driving unit Excor mobil for EXCOR VAD (D01E-001, 1400110, 1400066, 1400165, 1400021, 1600340, 1600342, 1400542, 1400543, 1400581, 1400551, 1400147, 1400516, 1400068, 1400705, 1400017)
心室辅助装置 EXCOR VAD 系统 (D03I-001, 1600190, 1600422, P10P-001, P15P-001, P25P-001x01, P30P-001x01, P50P-001, P60P-001, P80P-001, P50C-001, P60C-001, P80C-001, P80C-005, C60G-002, C60G-002m, C85G-002, C85G-002m, C60G-004, C60G-004, C60G-004, C85G-004, C85G-004, C85G-004, C85G-0004, C85G-000 4, C85G-000 04m, C80G-021, C80G-021m, C80G-040m, C00P-001, C00P-004, C22V-002, C22V-002M, C22V-004, C25V-004, C26V-002, C26V-002m, C23V-004m, C15V-040m, C19V-020, C19V-020m, C14A-040m, C18A-020, C22A-004, C27A-001, A06-009, A09-012, A06-006, A09-009, A12-012, T00L-002, L20H-002x01, L20H-003x01), 移动驱动单元 Excor mobil 用于 EXCOR VAD (D01E-001, 1400110, 1400066, 1400165, 1400021, 1600340, 1600342, 1400542, 1400543, 1400581, 1400551, 1400147, 1400516, 1400068, 1400705, 1400017)
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