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Ortéza členka so silikónovými pelotami, Sohatex, ČL-31, pravá
EUDAMEDClass I (EU MDR)
Ref J 77983Model Ankle-foot orthose
Identity
- Trade Name
- Ortéza členka so silikónovými pelotami, Sohatex, ČL-31, pravá EUDAMED
- Model / Reference
- Ankle-foot orthose EUDAMEDJ 77983 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585003409316 EUDAMED
- Basic UDI-DI
- 858500J77983CL31PXLRP EUDAMED
- Direct Marketing DI
- 08585003409316 EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT 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
Category: Ankle/foot orthosis
Ortéza členka so silikónovými pelotami, Sohatex, ČL-31, pravá by PROTETIKA, a.s. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ankle/foot orthosis.
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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 | 858500J77983CL31PXLRP | Class I | Active |
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Manufacturer
- Manufacturer
- PROTETIKA, a.s.
- EUDAMED SRN
- SK-MF-000004489
Sources (1)
- EUDAMED f8c16558-7aab-49d6-9bd7-cee175637878 61 fields · synced Oct 6, 2026