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Ortéza zápästia, laminovaný materiál, PRAVÁ, ZA-52
EUDAMEDClass I (EU MDR)
Ref J 94659Model Wrist-hand orthose
Identity
- Trade Name
- Ortéza zápästia,laminovaný materiál, PRAVÁ, ZA-52 EUDAMED
- Model / Reference
- Wrist-hand orthose EUDAMEDJ 94659 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585003410435 EUDAMED
- Basic UDI-DI
- 858500J94659ZA52PXLYF EUDAMED
- Direct Marketing DI
- 08585003410435 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, PRAVÁ, 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 | 858500J94659ZA52PXLYF | Class I | Active |
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Manufacturer
- Manufacturer
- PROTETIKA, a.s.
- EUDAMED SRN
- SK-MF-000004489
Sources (1)
- EUDAMED ab4558d3-89fc-49bc-a602-e50f3a2bf280 61 fields · synced Jun 18, 2026