Identity
- Trade Name
- Ortopedski uložak UNI RELAX, br.46 EUDAMED
- Device Name
- Ortopedski ulošci UNI RELAX EUDAMED
- Model / Reference
- 8105146 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858893980551 EUDAMED
- Basic UDI-DI
- 38588939881051285N EUDAMED
- Direct Marketing DI
- 03858893980551 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) 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
Category: Orthotic insole, prefabricated, non-antimicrobial
Ortopedski uložak UNI RELAX, br.46 by OTOS Ortopedska tehnika d.o.o. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthotic insole, prefabricated, non-antimicrobial.
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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 | 38588939881051285N | Class I | Active |
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Manufacturer
- Manufacturer
- OTOS Ortopedska tehnika d.o.o.
- EUDAMED SRN
- HR-MF-000040944
Sources (1)
- EUDAMED 5b80d6ea-9a73-42e0-a550-54e483c91fe3 61 fields · synced Jul 25, 2026