Identity
- Device Name
- Rom Knee Brace EUDAMED
- Model / Reference
- Rom Knee Brace (Universal) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906176122107 EUDAMED
- Basic UDI-DI
- 890617612M710DN EUDAMED
- Direct Marketing DI
- 08906176122107 EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Rom Knee Brace by Medequip Healthcare Solutions Pvt Ltd — 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 | 890617612M710DN | Class I | Active |
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Manufacturer
- Manufacturer
- Medequip Healthcare Solutions Pvt Ltd
- EUDAMED SRN
- IN-MF-000039598
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (1)
- EUDAMED 0f355988-0d58-4b7a-aaa8-9e218027ac4c 61 fields · synced Jun 18, 2026