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Traumastem P
EUDAMEDClass III (EU MDR)
Ref 60106Model Traumastem P, 3gRef 60107Model Traumastem P, 5gRef 10045Ref 10048
Identity
- Trade Name
- Traumastem P EUDAMEDTraumastem EUDAMED
- Device Name
- Haemostatic powder EUDAMEDTraumastem EUDAMED
- Model / Reference
- Traumastem P, 3g EUDAMED60106 EUDAMEDTraumastem P, 5g EUDAMED60107 EUDAMED10045 EUDAMED10048 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CZMF00001161560106L6 EUDAMEDD-CZMF00001161560107L8 EUDAMED18590317100450 EUDAMED18590317100481 EUDAMED
- Basic UDI-DI
- B-CZMF00001161560106L6 EUDAMEDB-CZMF00001161560107L8 EUDAMED85903170010SG 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 P by BIOSTER, a.s. — Class III — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-CZMF00001161560106L6 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-CZMF00001161560106L6 | Class III | Active |
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Manufacturer
- Manufacturer
- BIOSTER, a.s.
- EUDAMED SRN
- CZ-MF-000011615
Sources (4)
- EUDAMED 7a263a7e-341e-4d79-8712-a612310a77d1 61 fields · synced Jul 17, 2026
- EUDAMED 72686694-9b19-4371-9e53-738ecbad07c2 61 fields · synced May 18, 2026
- EUDAMED eb9edf16-d567-4d6a-92cd-84b1a1d1b939 61 fields · synced Jul 9, 2026
- EUDAMED c48ff01c-9d71-4395-87a2-e97ebc73a2f9 61 fields · synced Jul 17, 2026