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Ortéza ramena fixačná - Ľavá
EUDAMEDClass I (EU MDR)
Ref J 97730Model Shoulder orthoseRef 8585003410268
Identity
- Trade Name
- Ortéza ramena fixačná - Ľavá EUDAMEDOrtéza ramena fixačná, ľavá, RA-2 EUDAMED
- Model / Reference
- Shoulder orthose EUDAMEDJ 97730 EUDAMED8585003410268 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585003410268 EUDAMED
- Basic UDI-DI
- 858500J97730RA2LSMAU EUDAMED
- Direct Marketing DI
- 08585003410268 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 - Ľavá 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 | 858500J97730RA2LSMAU | Class I | Active |
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Manufacturer
- Manufacturer
- PROTETIKA, a.s.
- EUDAMED SRN
- SK-MF-000004489
Sources (2)
- EUDAMED b6841426-e7b8-484f-ad55-ae6fe9f052e8 61 fields · synced Jul 16, 2026
- EUDAMED ae6cfba3-6fab-4e9b-9f94-b14cf04775e2 61 fields · synced Jul 16, 2026