VitaFlow LibertyTM Delivery System, Loading Tool, Battery
by Shanghai MicroPort CardioFlow Medtech Co., Ltd. 4 variants
Ref DSR30, LT-30, BAT1200
Active
CE MDR
Valid until
1 Apr 2029
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6126688CE01 | Date15 Oct 2025 | StatusActive |
Certificates
- 6126688CE01 Active
Quality management system EU MDR
- Certifier
- DEKRA Certification B.V. 0344
- Issued
- 15 Oct 2025
- Expires
- 1 Apr 2029
- Reason
- Mnf data change
- 6126688TD01 Active
Technical documentation EU MDR
- Certifier
- DEKRA Certification B.V. 0344
- Issued
- 15 Oct 2025
- Expires
- 1 Apr 2029
- Reason
- Mnf data change
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- VitaFlow LibertyTM Transcatheter Aortic Valve System
- Model / Reference
- DSR30, LT-30, BAT1200
- Primary DI / UDI-DI
- 06971493530661
- Basic UDI-DI
- 697149353Z0213CEEU
- EMDN Code
- P07038002 Cardiac valve transcatheter implant accessories
- Device Class
- Class III
- EU market of registration
- Denmark
Manufacturer details
- EUDAMED SRN
- CN-MF-000002327
- Authorised representative
- MicroPort Medical B.V. NL-AR-000000166
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Properties
Other properties (10)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No