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Rom Walker – Lux – S
EUDAMEDClass I (EU MDR)
Ref ML-0116-5
by Beyazgrup Sağlik Ürünleri̇ İmalat Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇
Identity
- Trade Name
- Rom Walker – Lux – S EUDAMED
- Device Name
- İSTİRAHAT MOLDU(P.A.F.O) - SMALL EUDAMED
- Model / Reference
- ML-0116-5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680702030592 EUDAMED
- Basic UDI-DI
- 86807020ORTEZVK EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Rom Walker – Lux – S by Beyazgrup Sağlik Ürünleri̇ İmalat Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇ — Class I — MDR — listed in EUDAMED
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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 | 86807020ORTEZVK | Class I | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000031770
Sources (1)
- EUDAMED 2769b102-3abe-4c7c-9ac2-ca08e928abfe 61 fields · synced Sep 26, 2026