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Flexsoft Duo
EUDAMEDClass I (EU MDR)
Ref FD12GModel FLEXSOFT DUORef FD11GRef FD12D
by Orthosoft
Identity
- Trade Name
- FLEXSOFT DUO EUDAMED
- Device Name
- FLEXSOFT DUO EUDAMED
- Model / Reference
- FLEXSOFT DUO EUDAMEDFD12G EUDAMEDFD11G EUDAMEDFD12D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760270340059 EUDAMED03760270340066 EUDAMED03760270340073 EUDAMED
- Basic UDI-DI
- 37602703434015618358A EUDAMED
- EMDN Code
- Y060613 WRIST-HAND-FINGERS 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 Duo 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 | 37602703434015618358A | Class I | Active |
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Manufacturer
- Manufacturer
- Orthosoft
- EUDAMED SRN
- FR-MF-000000216
Sources (3)
- EUDAMED a86c5fbf-3250-4fca-8d37-7b9091e5a24e 61 fields · synced Aug 2, 2026
- EUDAMED f28786e8-a341-43e0-a004-0ae52e1c590a 61 fields · synced May 17, 2026
- EUDAMED bdaee22f-fe4e-456d-b4f9-d1fa7eee9565 61 fields · synced May 18, 2026