← Back to catalogue
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
- 08585003409293 EUDAMED
- Basic UDI-DI
- 858500J77983CL31PM8G EUDAMED
- Direct Marketing DI
- 08585003409293 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
Ortéza členka so silikónovými pelotami, Sohatex, ČL-31, 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 | 858500J77983CL31PM8G | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PROTETIKA, a.s.
- EUDAMED SRN
- SK-MF-000004489
Sources (1)
- EUDAMED 80809583-c7b1-47af-85ee-2d629cb45ac8 61 fields · synced Oct 6, 2026