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Neoprénová bandáž zápästia, ZA-1
EUDAMEDClass I (EU MDR)
Ref 8585003407947Model Wrist orthose
Identity
- Trade Name
- Neoprénová bandáž zápästia, ZA-1 EUDAMED
- Model / Reference
- Wrist orthose EUDAMED8585003407947 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585003407947 EUDAMED
- Basic UDI-DI
- 858500J22118ZA1XSS3K EUDAMED
- Direct Marketing DI
- 08585003407947 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, ZA-1 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 | 858500J22118ZA1XSS3K | Class I | Active |
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Manufacturer
- Manufacturer
- PROTETIKA, a.s.
- EUDAMED SRN
- SK-MF-000004489
Sources (1)
- EUDAMED 31b4aa41-d80a-4e1b-9c10-bb0c3c4d5fd5 61 fields · synced Oct 6, 2026