Identity
- Trade Name
- Traumastem Non-Woven EUDAMED
- Device Name
- Traumastem EUDAMED
- Model / Reference
- 10054 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18590317100542 EUDAMED
- Basic UDI-DI
- 85903170010SG EUDAMED
- EMDN Code
- M040501 POLYSACCHARIDE HAEMOSTATIC DRESSINGS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Traumastem Non-Woven by BIOSTER, a.s. — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 85903170010SG | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BIOSTER, a.s.
- EUDAMED SRN
- CZ-MF-000011615
Sources (1)
- EUDAMED ba64c8ab-b3bc-4de0-bc5c-69d5e4d3c6ba 61 fields · synced Jul 13, 2026