Identity
- Trade Name
- Manžeta za imobilizaciju gležnja, šnala EUDAMED
- Device Name
- Remenje za humanu imobilizaciju EUDAMED
- Model / Reference
- 9700024 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858893981244 EUDAMED
- Basic UDI-DI
- 385889398970001778 EUDAMED
- Direct Marketing DI
- 03858893981244 EUDAMED
- EMDN Code
- V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Croatia 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
Manžeta za imobilizaciju gležnja, šnala by OTOS Ortopedska tehnika d.o.o. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 385889398970001778 | Class I | Active |
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Manufacturer
- Manufacturer
- OTOS Ortopedska tehnika d.o.o.
- EUDAMED SRN
- HR-MF-000040944
Sources (1)
- EUDAMED 5c8f9bf7-82ab-4159-ab14-c6b7514ec075 61 fields · synced Oct 6, 2026