← Back to catalogue
Flexsoft
EUDAMEDClass I (EU MDR)
Ref FL12DModel FLEXSOFTRef FL12GRef FL11G
by Orthosoft
Identity
- Trade Name
- FLEXSOFT EUDAMED
- Device Name
- FLEXSOFT EUDAMED
- Model / Reference
- FLEXSOFT EUDAMEDFL12D EUDAMEDFL12G EUDAMEDFL11G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760270340264 EUDAMED03760270340240 EUDAMED03760270340257 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Orthosoft
- EUDAMED SRN
- FR-MF-000000216
Sources (3)
- EUDAMED 44b12617-e756-4878-b757-f5b29ae1a72e 61 fields · synced Jul 14, 2026
- EUDAMED 118ae264-5b55-46b2-a0a9-3fcfaa5f38f7 61 fields · synced May 17, 2026
- EUDAMED 92a090ed-975a-4a7b-92e7-a2352373db09 61 fields · synced May 19, 2026