Identity
- Trade Name
- MU2net EUDAMED
- Device Name
- MU2net EUDAMED
- Model / Reference
- MU1001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B501MU2NET0201010 EUDAMED
- Basic UDI-DI
- B-+B501MU2NET0201010 EUDAMED
- EMDN Code
- Z11019092 VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
MU2net by Dosisoft — Class I — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191944 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-+B501MU2NET0201010 | Class I | Active |
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Manufacturer
- Manufacturer
- Dosisoft
- EUDAMED SRN
- FR-MF-000014706
Sources (2)
- EUDAMED cf88bb03-b469-4f4f-8186-d7efce1a57f2 61 fields · synced Jul 30, 2026
- FDA 510(k) K191944 1 fields · synced May 18, 2026