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Traumastem POWDER
EUDAMEDClass III (EU MDR)
Ref 60263Model Traumastem POWDER, 2gRef 60266Model Traumastem POWDER, 5gRef 60112Ref 60113Model Traumastem POWDER, 1gRef 60264Ref 60114Model Traumastem POWDER, 3g
Identity
- Trade Name
- Traumastem POWDER EUDAMED
- Device Name
- Haemostatic powder EUDAMED
- Model / Reference
- Traumastem POWDER, 2g EUDAMED60263 EUDAMEDTraumastem POWDER, 5g EUDAMED60266 EUDAMED60112 EUDAMEDTraumastem POWDER, 1g EUDAMED60113 EUDAMED60264 EUDAMEDTraumastem POWDER, 3g EUDAMED60114 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CZMF00001161560263LP EUDAMEDD-CZMF00001161560266LV EUDAMEDD-CZMF00001161560112KZ EUDAMEDD-CZMF00001161560113L3 EUDAMEDD-CZMF00001161560264LR EUDAMEDD-CZMF00001161560114L5 EUDAMED
- Basic UDI-DI
- B-CZMF00001161560263LP EUDAMEDB-CZMF00001161560266LV EUDAMEDB-CZMF00001161560112KZ EUDAMEDB-CZMF00001161560113L3 EUDAMEDB-CZMF00001161560264LR EUDAMEDB-CZMF00001161560114L5 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-CZMF00001161560263LP | Class III | Active |
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Manufacturer
- Manufacturer
- BIOSTER, a.s.
- EUDAMED SRN
- CZ-MF-000011615
Sources (6)
- EUDAMED bd519f47-872f-4b9b-b1fe-4e6959349168 61 fields · synced Jul 10, 2026
- EUDAMED 79e00531-6387-4af4-bd3c-e3b67fe70386 61 fields · synced May 17, 2026
- EUDAMED fffac118-90cd-426a-9a35-a0b9efcacaab 61 fields · synced May 17, 2026
- EUDAMED 59c42e84-6337-483e-9f2c-1ce7230969a8 61 fields · synced May 18, 2026
- EUDAMED 5b5a08e3-138a-436f-bde2-5f2719154dba 61 fields · synced May 18, 2026
- EUDAMED 6c4adde7-a926-4d20-9195-629b69836613 61 fields · synced May 19, 2026