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Ortéza ramena fixačná
EUDAMEDClass I (EU MDR)
Ref J 97729Model Shoulder orthoseRef 8585003401044
Identity
- Trade Name
- Ortéza ramena fixačná EUDAMEDOrtéza ramena fixačná RA-1 EUDAMED
- Model / Reference
- Shoulder orthose EUDAMEDJ 97729 EUDAMED8585003401044 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585003401044 EUDAMED
- Basic UDI-DI
- 858500J97729RA1SQ3 EUDAMED
- Direct Marketing DI
- 08585003401044 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 | 858500J97729RA1SQ3 | Class I | Active |
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Manufacturer
- Manufacturer
- PROTETIKA, a.s.
- EUDAMED SRN
- SK-MF-000004489
Sources (2)
- EUDAMED 50578867-3f91-46e5-89f2-561f45c61a7b 61 fields · synced Jul 11, 2026
- EUDAMED a995db96-644b-4a33-9ab2-4f139d555189 61 fields · synced Jul 11, 2026