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Ortéza zápästia, laminovaný materiál, PRAVÁ, ZA-51
EUDAMEDClass I (EU MDR)
Ref j 94658Model Wrist-hand orthoseRef J 94658
Identity
- Trade Name
- Ortéza zápästia,laminovaný materiál, PRAVÁ,ZA-51 EUDAMEDOrtéza zápästia, laminovaný materiál, PRAVÁ, ZA-51 EUDAMED
- Model / Reference
- Wrist-hand orthose EUDAMEDj 94658 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585003406742 EUDAMED08585003406728 EUDAMED
- Basic UDI-DI
- 858500J94658ZA51PMCE EUDAMED858500J94658ZA51PSCS EUDAMED
- Direct Marketing DI
- 08585003406742 EUDAMED08585003406728 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-51 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 | 858500J94658ZA51PMCE | Class I | Active |
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Manufacturer
- Manufacturer
- PROTETIKA, a.s.
- EUDAMED SRN
- SK-MF-000004489
Sources (2)
- EUDAMED 4ebdacae-61e0-4c1a-b5f5-c46dba0c0eff 61 fields · synced Jul 17, 2026
- EUDAMED 7167d989-73e9-403b-91eb-88fb854a59d2 61 fields · synced May 19, 2026