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Ortéza zápästia, laminovaný materiál, ĽAVÁ, ZA-52
EUDAMEDClass I (EU MDR)
Ref J 94659Model Wrist-hand orthose
Identity
- Trade Name
- Ortéza zápästia,laminovaný materiál,ĽAVÁ,ZA-52 EUDAMED
- Model / Reference
- Wrist-hand orthose EUDAMEDJ 94659 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585003410367 EUDAMED08585003410381 EUDAMED
- Basic UDI-DI
- 858500J94659ZA52LSD4 EUDAMED858500J94659ZA52LMCQ EUDAMED
- Direct Marketing DI
- 08585003410367 EUDAMED08585003410381 EUDAMED
- EMDN Code
- Y060612 WRIST-HAND 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 zápästia, laminovaný materiál, ĽAVÁ, ZA-52 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 | 858500J94659ZA52LSD4 | Class I | Active |
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Manufacturer
- Manufacturer
- PROTETIKA, a.s.
- EUDAMED SRN
- SK-MF-000004489
Sources (2)
- EUDAMED cbf839b6-9483-44d1-a169-62be5ae60e20 61 fields · synced Aug 2, 2026
- EUDAMED b09feeb9-49eb-48cb-82b0-c906e9718f59 61 fields · synced May 19, 2026