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Neoprénová bandáž zápästia ĽAVÁ , ZA-4
EUDAMEDClass I (EU MDR)
Ref J22121Model Wrist - hand orthoseRef 8585003408043Model Wrist orthose
Identity
- Trade Name
- Neoprénová bandáž zápästia ĽAVÁ ,ZA-4 EUDAMEDNeoprénová bandáž zápästia ZA-4, ľavá EUDAMED
- Model / Reference
- Wrist - hand orthose EUDAMEDJ22121 EUDAMEDWrist orthose EUDAMED8585003408043 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585003408043 EUDAMED
- Basic UDI-DI
- 858500J22121ZA4LSKF EUDAMED
- Direct Marketing DI
- 08585003408043 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
Neoprénová bandáž zápästia ĽAVÁ , ZA-4 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 | 858500J22121ZA4LSKF | Class I | Active |
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Manufacturer
- Manufacturer
- PROTETIKA, a.s.
- EUDAMED SRN
- SK-MF-000004489
Sources (2)
- EUDAMED 85646567-d602-4b80-891d-10eb1e20c3b4 61 fields · synced Jun 18, 2026
- EUDAMED 409dd9b3-f7d3-4142-8da6-ac9af93eadd1 61 fields · synced Jun 14, 2026