Identity
- Trade Name
- Re-Flex Rotate™ EUDAMED
- Model / Reference
- BU00051 EUDAMEDRHPE5250 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05690977324527 EUDAMED
- Basic UDI-DI
- 5690967BU00051NA 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
Re-Flex Rotate™ 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 | 5690967BU00051NA | Class I | Active |
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Manufacturer
- Manufacturer
- Össur Iceland ehf.
- EUDAMED SRN
- IS-MF-000000173
Sources (1)
- EUDAMED b082e9f1-9037-45b9-82e0-d93baea8b489 61 fields · synced Sep 18, 2026