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Manusoft
EUDAMEDClass I (EU MDR)
Ref MU11GModel MANUSOFTRef MU12GRef MU11D
by Orthosoft
Identity
- Trade Name
- MANUSOFT EUDAMED
- Device Name
- MANUSOFT EUDAMED
- Model / Reference
- MANUSOFT EUDAMEDMU11G EUDAMEDMU12G EUDAMEDMU11D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760270340127 EUDAMED03760270340110 EUDAMED03760270340141 EUDAMED
- Basic UDI-DI
- 37602703434010774587N 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
Manusoft 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 | 37602703434010774587N | Class I | Active |
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Manufacturer
- Manufacturer
- Orthosoft
- EUDAMED SRN
- FR-MF-000000216
Sources (3)
- EUDAMED 45b3d48d-a8ee-42d1-bfbe-4b61eab73603 61 fields · synced Jul 31, 2026
- EUDAMED 9cf0faef-6cb4-493b-ac68-c9e427a424e4 61 fields · synced May 18, 2026
- EUDAMED ffb0fc86-6108-4ce2-991f-c09d1afcf0ea 61 fields · synced May 18, 2026