EpiHeart Transplant Holder
by EpiHeart Oy EUDAMED
Active
Ref 64-000-002
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6429810632TRAHOL017E | Date3 Oct 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Transplant Holder
- Model / Reference
- 64-000-002
- Primary DI / UDI-DI
- 06429810632111
- Basic UDI-DI
- 6429810632TRAHOL017E
- EMDN Code
- V0499 Clinical use containers (non-IVD) - other
- Device Class
- Class I
- Market of Registration
- Finland
Manufacturer details
- EUDAMED SRN
- FI-MF-000018287
Other devices from EpiHeart Oy
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No