Identity
- Trade Name
- Traumastem ENDO Applicator EUDAMED
- Device Name
- Endoscopic applicator of haemostatic powder EUDAMED
- Model / Reference
- 60189 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CZMF00001161560189M4 EUDAMED
- Basic UDI-DI
- B-CZMF00001161560189M4 EUDAMED
- EMDN Code
- W0202029085 VARIOUS HEMOSTASIS INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa 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 ENDO Applicator by BIOSTER, a.s. — Class IIa — 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-CZMF00001161560189M4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- BIOSTER, a.s.
- EUDAMED SRN
- CZ-MF-000011615
Sources (1)
- EUDAMED a3ecfb6e-0870-4730-9141-f33574684e31 61 fields · synced Jun 18, 2026