Identity
- Trade Name
- Nike Sole EUDAMED
- Model / Reference
- BU00100 EUDAMEDCM150163 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05690977343597 EUDAMED
- Basic UDI-DI
- 5690967BU00100MW EUDAMED
- EMDN Code
- Y062403 FOOT PARTIAL PROSTHESES (INCLUDING TOE PROSTHESES) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Nike Sole by Össur Iceland ehf. — 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 | 5690967BU00100MW | Class I | Active |
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Manufacturer
- Manufacturer
- Össur Iceland ehf.
- EUDAMED SRN
- IS-MF-000000173
Sources (1)
- EUDAMED 6f2d57a3-2669-47ec-87f6-6418e5a1a883 61 fields · synced Aug 4, 2026