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Traumacel PULVIS
EUDAMEDClass III (EU MDR)
Ref 60259Model Traumacel PULVIS, 1gRef 60182Model Traumacel PULVIS, 3gRef 60183Model Traumacel PULVIS, 5g
Identity
- Trade Name
- Traumacel PULVIS EUDAMED
- Device Name
- Haemostatic powder EUDAMED
- Model / Reference
- Traumacel PULVIS, 1g EUDAMED60259 EUDAMEDTraumacel PULVIS, 3g EUDAMED60182 EUDAMEDTraumacel PULVIS, 5g EUDAMED60183 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CZMF00001161560259LY EUDAMEDD-CZMF00001161560182LN EUDAMEDD-CZMF00001161560183LQ EUDAMED
- Basic UDI-DI
- B-CZMF00001161560259LY EUDAMEDB-CZMF00001161560182LN EUDAMEDB-CZMF00001161560183LQ 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 PULVIS 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-CZMF00001161560259LY | Class III | Active |
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Manufacturer
- Manufacturer
- BIOSTER, a.s.
- EUDAMED SRN
- CZ-MF-000011615
Sources (3)
- EUDAMED 4499f939-b607-4455-b3a0-164de8b9d10b 61 fields · synced Jul 25, 2026
- EUDAMED 9ff64904-9cd2-4fab-90c9-181c4465777c 61 fields · synced May 18, 2026
- EUDAMED 285c779d-2ca1-4bdc-a974-3cca5d84fbe1 61 fields · synced May 19, 2026