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Ortéza ramena fixačná
EUDAMEDClass I (EU MDR)
Ref J 97729Model Shoulder orthoseRef 8585003401068
Identity
- Trade Name
- Ortéza ramena fixačná EUDAMEDOrtéza ramena fixačné RA-1 EUDAMED
- Model / Reference
- Shoulder orthose EUDAMEDJ 97729 EUDAMED8585003401068 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585003401068 EUDAMED
- Basic UDI-DI
- 858500J97729RA1LPM EUDAMED
- Direct Marketing DI
- 08585003401068 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 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 | 858500J97729RA1LPM | Class I | Active |
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Manufacturer
- Manufacturer
- PROTETIKA, a.s.
- EUDAMED SRN
- SK-MF-000004489
Sources (2)
- EUDAMED a45f268c-66b0-44b1-95e4-e279b110a79c 61 fields · synced Jul 9, 2026
- EUDAMED 86388963-359d-4a8f-acd6-cef3852b6477 61 fields · synced Jul 9, 2026