Identity
- Trade Name
- McDavid EUDAMED
- Device Name
- Runner's Therapy: Plantar Fasciitis Sleeve EUDAMED
- Model / Reference
- MD4101 EUDAMEDMD4101-01-35L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00029369138568 EUDAMED
- Basic UDI-DI
- 00029369MD4101U6 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 | 00029369MD4101U6 | 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 ab76ba1e-4d6e-4996-a602-941e3d7e5acc 61 fields · synced Jun 19, 2026