Identity
- Trade Name
- Walker with Rom hinge - S EUDAMED
- Device Name
- Ankle support EUDAMED
- Model / Reference
- 5336-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05206210173021 EUDAMED
- Basic UDI-DI
- 5206210ANKLEKS EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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
Walker with Rom hinge - S by Μιχαλης Κουγιουμτζης Και Σια Ε.ε. — 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 | 5206210ANKLEKS | Class I | Active |
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Manufacturer
- Manufacturer
- Μιχαλης Κουγιουμτζης Και Σια Ε.ε.
- EUDAMED SRN
- GR-MF-000015985
Sources (1)
- EUDAMED 4daac048-4151-489b-b8a2-73d028f6b06e 61 fields · synced Jun 18, 2026