Identity
- Device Name
- Ankle Brace EUDAMED
- Model / Reference
- Ankle Brace (M) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906176120134 EUDAMED
- Basic UDI-DI
- 890617612M801DS EUDAMED
- Direct Marketing DI
- 08906176120134 EUDAMED
- EMDN Code
- Y061218 HIP-KNEE-ANKLE-FOOT 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
Ankle 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 | 890617612M801DS | 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 c109fda9-8c58-4b29-b6f5-b6e3b131fee1 61 fields · synced Jun 18, 2026