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Ortéza zápästia ZA-43, bez výstuže
EUDAMEDClass I (EU MDR)
Ref 8585063863790Model Wrist-hand orthose
Identity
- Trade Name
- Ortéza zápästia ZA-43, bez výstuže EUDAMED
- Model / Reference
- Wrist-hand orthose EUDAMED8585063863790 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585063863790 EUDAMED
- Basic UDI-DI
- 858506ZA43XXLCT EUDAMED
- Direct Marketing DI
- 08585063863790 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 ZA-43, bez výstuže 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 | 858506ZA43XXLCT | Class I | Active |
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Manufacturer
- Manufacturer
- PROTETIKA, a.s.
- EUDAMED SRN
- SK-MF-000004489
Sources (1)
- EUDAMED ac40934f-0ddd-46b7-9956-454b5aa0c714 61 fields · synced Jul 13, 2026