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Neoprénová bandáž členka, ČL-4
EUDAMEDClass I (EU MDR)
Ref J 58376Model Ankle-foot orthose
Identity
- Trade Name
- Neoprénová bandáž členka, ČL-4 EUDAMED
- Model / Reference
- Ankle-foot orthose EUDAMEDJ 58376 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08585003412873 EUDAMED
- Basic UDI-DI
- 858500J58376CL4MJZ EUDAMED
- Direct Marketing DI
- 08585003412873 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
Neoprénová bandáž členka, ČL-4 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 | 858500J58376CL4MJZ | Class I | Active |
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Manufacturer
- Manufacturer
- PROTETIKA, a.s.
- EUDAMED SRN
- SK-MF-000004489
Sources (1)
- EUDAMED e3d33d1d-b78a-4d33-988c-bc3934f5e08d 61 fields · synced Jun 14, 2026