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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
- 08585003410374 EUDAMED08585003410411 EUDAMED08585003410398 EUDAMED
- Basic UDI-DI
- 858500J94659ZA52PSDG EUDAMED858500J94659ZA52PLD2 EUDAMED858500J94659ZA52PMD4 EUDAMED
- Direct Marketing DI
- 08585003410374 EUDAMED08585003410411 EUDAMED08585003410398 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 | 858500J94659ZA52PSDG | Class I | Active |
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Manufacturer
- Manufacturer
- PROTETIKA, a.s.
- EUDAMED SRN
- SK-MF-000004489
Sources (3)
- EUDAMED b95c2219-cca9-4f5f-9458-b2a8c2bf8189 61 fields · synced Oct 6, 2026
- EUDAMED e6b4f10b-08e6-4b2e-b853-731d86b12a45 61 fields · synced May 19, 2026
- EUDAMED 9d0f3a01-c46d-4be4-bf0c-2add52dbaa45 61 fields · synced May 19, 2026