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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
- 08585003410428 EUDAMED
- Basic UDI-DI
- 858500J94659ZA52LXLXT EUDAMED
- Direct Marketing DI
- 08585003410428 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 | 858500J94659ZA52LXLXT | Class I | Active |
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Manufacturer
- Manufacturer
- PROTETIKA, a.s.
- EUDAMED SRN
- SK-MF-000004489
Sources (1)
- EUDAMED 2c864875-7201-452e-bc89-7d519d3409b7 61 fields · synced Jun 18, 2026