Identity
- Trade Name
- Traumacel TAF EUDAMED
- Device Name
- Traumastem EUDAMED
- Model / Reference
- 10139 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18590317101396 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
Traumacel TAF 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 |
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Manufacturer
- Manufacturer
- BIOSTER, a.s.
- EUDAMED SRN
- CZ-MF-000011615
Sources (1)
- EUDAMED 2e106fdb-0be8-40f0-8583-b9c5b708f287 61 fields · synced Jul 23, 2026