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Ortéza lakťa s dlahami, Sohatex, LA-32
EUDAMEDClass I (EU MDR)
Ref J 80832Model Elbow orthose with splintsRef 8585003406094
Identity
- Trade Name
- Ortéza lakťa s dlahami, Sohatex, LA-32 EUDAMED
- Model / Reference
- Elbow orthose with splints EUDAMEDJ 80832 EUDAMED8585003406094 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585003406094 EUDAMED
- Basic UDI-DI
- 858500J80832LA32XLXH EUDAMED
- Direct Marketing DI
- 08585003406094 EUDAMED
- EMDN Code
- Y060615 ELBOW ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Slovakia 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
Ortéza lakťa s dlahami, Sohatex, LA-32 by PROTETIKA, a.s. — 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 | 858500J80832LA32XLXH | Class I | Active |
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Manufacturer
- Manufacturer
- PROTETIKA, a.s.
- EUDAMED SRN
- SK-MF-000004489
Sources (2)
- EUDAMED cbba31f5-347c-4506-80f5-3e2f86ec1d86 61 fields · synced Jun 18, 2026
- EUDAMED bfe43f1e-e861-4706-b01f-4f40c994a37b 61 fields · synced Jun 18, 2026