Identity
- Trade Name
- Schanzova kravata, vel. XL EUDAMED
- Device Name
- Schanzova kravata EUDAMED
- Model / Reference
- 5096195 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858893981107 EUDAMED
- Basic UDI-DI
- 38588939850961937B EUDAMED
- Direct Marketing DI
- 03858893981107 EUDAMED
- EMDN Code
- Y060312 CERVICAL SPINE ORTHOSES 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
Schanzova kravata, vel. XL 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 | 38588939850961937B | Class I | Active |
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Manufacturer
- Manufacturer
- OTOS Ortopedska tehnika d.o.o.
- EUDAMED SRN
- HR-MF-000040944
Sources (1)
- EUDAMED b4dc75ee-e4ca-409a-998a-7c1d4ebeb28b 61 fields · synced Oct 6, 2026