Traumastem
by BIOSTER, a.s. EUDAMED
Active
Ref 10047
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number85903170010SG | Date7 May 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
- 24 0146 TD/NB Active
Technical documentation EU MDR
- Notified body
- 1023
- Issued
- 29 Apr 2024
- Expires
- 28 Apr 2029
Specification
- Model / Reference
- 10047
- Primary DI / UDI-DI
- 18590317100474
- Basic UDI-DI
- 85903170010SG
- EMDN Code
- M040501 Polysaccharide haemostatic dressings
- Device Class
- Class III
- Market of Registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CZ-MF-000011615
Other devices from BIOSTER, a.s.
Properties
Other properties (12)
- 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