Identity
- Trade Name
- McDavid EUDAMED
- Device Name
- Ankle Brace / Lace-up With Stays EUDAMED
- Model / Reference
- MD199.AM EUDAMED199R.AM-BK-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404034675961 EUDAMED
- Basic UDI-DI
- 05404034MD199.AMPF 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
Category: Ankle/foot orthosis
McDavid by United Sports Brands — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 05404034MD199.AMPF | 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 ca5e68af-ceaa-498b-b3f7-ce5ee8b96c4e 61 fields · synced Jun 18, 2026