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Ortéza ramena fixačná - Pravá
EUDAMEDClass I (EU MDR)
Ref J 97730Model Shoulder orthoseRef 8585003410251
Identity
- Trade Name
- Ortéza ramena fixačná - Pravá EUDAMEDOrtéza ramena fixačná, pravá, RA-2 EUDAMED
- Model / Reference
- Shoulder orthose EUDAMEDJ 97730 EUDAMED8585003410251 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585003410251 EUDAMED
- Basic UDI-DI
- 858500J97730RA2PLXLVW EUDAMED
- Direct Marketing DI
- 08585003410251 EUDAMED
- EMDN Code
- Y060621 SHOULDER 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 ramena fixačná - Pravá 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 | 858500J97730RA2PLXLVW | Class I | Active |
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Manufacturer
- Manufacturer
- PROTETIKA, a.s.
- EUDAMED SRN
- SK-MF-000004489
Sources (2)
- EUDAMED 0475d80b-8777-4eb8-8651-1959bcf82725 61 fields · synced Jul 30, 2026
- EUDAMED 98557634-8e93-4cbc-8efd-b9e88dcbaad0 61 fields · synced Jul 30, 2026