Identity
- Trade Name
- UNISPLINT - fixační dlaha EUDAMED
- Device Name
- UNISPLINT fixation splint EUDAMED
- Model / Reference
- 15002 EUDAMED15007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18590317150028 EUDAMED18590317150073 EUDAMED
- Basic UDI-DI
- 85903170001SF EUDAMED
- EMDN Code
- M03050202 SYNTHETIC CAST BANDAGES AND SPLINTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
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
Category: Cotton wool roll, sterile
UNISPLINT - fixační dlaha by BIOSTER, a.s. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 85903170001SF | Class I | Active |
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Manufacturer
- Manufacturer
- BIOSTER, a.s.
- EUDAMED SRN
- CZ-MF-000011615
Sources (2)
- EUDAMED 51962d37-bac2-4038-9d62-bce204ba3028 61 fields · synced Jul 21, 2026
- EUDAMED 8bdc95d0-e715-46f3-9194-bd9001bc73d6 61 fields · synced May 19, 2026