Identity
- Trade Name
- MANUSOFT EUDAMED
- Device Name
- MANUSOFT EUDAMED
- Model / Reference
- MANUSOFT EUDAMEDMU12D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760270340134 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 (1)
- EUDAMED 7082a9f9-3c2e-4521-8b3c-fbc2a1824a2b 61 fields · synced Jun 17, 2026