Identity
- Trade Name
- McDavid EUDAMED
- Device Name
- Knee Sleeve 4 Way Elastic w/ Gel Buttress and Stays EUDAMED
- Model / Reference
- MD5116 EUDAMEDMD5116-01-34 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00029369124653 EUDAMED
- Basic UDI-DI
- 00029369MD5116US EUDAMED
- EMDN Code
- Y061209 KNEE 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 | 00029369MD5116US | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- United Sports Brands
- EUDAMED SRN
- US-MF-000008428
- Authorised Representative
- QNET B.V. NL-AR-000002695
Sources (1)
- EUDAMED bf0496cf-0c11-4f10-9478-352624240b03 61 fields · synced Jun 18, 2026