Identity
- Trade Name
- Traumacel ENDO Applicator EUDAMED
- Device Name
- Endoscopic applicator of haemostatic powder EUDAMED
- Model / Reference
- 60188 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CZMF00001161560188M2 EUDAMED
- Basic UDI-DI
- B-CZMF00001161560188M2 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
Traumacel 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-CZMF00001161560188M2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- BIOSTER, a.s.
- EUDAMED SRN
- CZ-MF-000011615
Sources (1)
- EUDAMED ffa29539-4750-4c30-b661-5ab10c64eeb7 61 fields · synced Jun 19, 2026