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Ortéza zápästia s výstuhou dlaňovej strany, Sohatex, PRAVÁ, ZA-31
EUDAMEDClass I (EU MDR)
Ref J 80831Model Wrist-hand orthose
Identity
- Trade Name
- Ortéza zápästia s výstuhou dlaňovej strany, Sohatex, PRAVÁ, ZA-31 EUDAMED
- Model / Reference
- Wrist-hand orthose EUDAMEDJ 80831 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585003408203 EUDAMED08585003408166 EUDAMED08585003408180 EUDAMED
- Basic UDI-DI
- 858500J80831ZA31PS4A EUDAMED858500J80831ZA31PL3U EUDAMED858500J80831ZA31PM3W EUDAMED
- Direct Marketing DI
- 08585003408203 EUDAMED08585003408166 EUDAMED08585003408180 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 s výstuhou dlaňovej strany, Sohatex, PRAVÁ, ZA-31 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 | 858500J80831ZA31PS4A | Class I | Active |
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Manufacturer
- Manufacturer
- PROTETIKA, a.s.
- EUDAMED SRN
- SK-MF-000004489
Sources (3)
- EUDAMED 547288c0-8df6-476d-b5a5-e6dbe95ffe7a 61 fields · synced Oct 6, 2026
- EUDAMED 909191a9-8028-4261-9ad4-d8db6d01cd85 61 fields · synced May 17, 2026
- EUDAMED 39079202-30ee-4024-b189-4ae4627c25ca 61 fields · synced May 17, 2026