← Back to catalogue
Neoprénová bandáž zápästia, ZA-1
EUDAMEDClass I (EU MDR)
Ref 8585003407961Model Wrist orthose
Identity
- Trade Name
- Neoprénová bandáž zápästia, ZA-1 EUDAMED
- Model / Reference
- Wrist orthose EUDAMED8585003407961 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585003407961 EUDAMED
- Basic UDI-DI
- 858500J22118ZA1XLXXL9M EUDAMED
- Direct Marketing DI
- 08585003407961 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 | 858500J22118ZA1XLXXL9M | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PROTETIKA, a.s.
- EUDAMED SRN
- SK-MF-000004489
Sources (1)
- EUDAMED 4fb5e182-bc11-4f03-b99f-2422e8297b47 61 fields · synced Jun 18, 2026