Identity
- Trade Name
- FLEXSOFT EUDAMED
- Device Name
- FLEXSOFT EUDAMED
- Model / Reference
- FLEXSOFT EUDAMEDFL11D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760270340271 EUDAMED
- Basic UDI-DI
- 37602703434010449376H EUDAMED
- EMDN Code
- Y060612 WRIST-HAND ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Flexsoft by Orthosoft — 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 | 37602703434010449376H | Class I | Active |
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Manufacturer
- Manufacturer
- Orthosoft
- EUDAMED SRN
- FR-MF-000000216
Sources (1)
- EUDAMED 5b7327d7-479d-40de-bb1a-849dec941789 61 fields · synced Jun 19, 2026