Identity
- Trade Name
- McDavid EUDAMED
- Device Name
- Bio-Logix Ankle Brace EUDAMED
- Model / Reference
- MD4197 EUDAMEDMD4197-01-25L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00029369138650 EUDAMED
- Basic UDI-DI
- 00029369MD4197VD EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
McDavid by United Sports Brands — 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 | 00029369MD4197VD | Class I | Active |
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Manufacturer
- Manufacturer
- United Sports Brands
- EUDAMED SRN
- US-MF-000008428
- Authorised Representative
- QNET B.V. NL-AR-000002695
Sources (1)
- EUDAMED 554ca02c-47ce-4ef9-b0c1-f39d0bafe74c 61 fields · synced Jun 19, 2026