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Traumastem POWDER
EUDAMEDClass III (EU MDR)
Ref 60115Model Traumastem POWDER, 5g
Identity
- Trade Name
- Traumastem POWDER EUDAMED
- Device Name
- Haemostatic powder EUDAMED
- Model / Reference
- Traumastem POWDER, 5g EUDAMED60115 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CZMF00001161560115L7 EUDAMED
- Basic UDI-DI
- B-CZMF00001161560115L7 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 POWDER by BIOSTER, a.s. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-CZMF00001161560115L7 | Class III | Active |
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Manufacturer
- Manufacturer
- BIOSTER, a.s.
- EUDAMED SRN
- CZ-MF-000011615
Sources (1)
- EUDAMED 8168c011-083d-4950-ba73-7f216b9c7e73 61 fields · synced Jun 18, 2026