Identity
- Trade Name
- MOZI TPS EUDAMED
- Device Name
- MOZI Treatment Planning System (MOZI TPS) EUDAMED
- Model / Reference
- MOZI EUDAMEDMZ0081 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973127400081 EUDAMED
- Basic UDI-DI
- 697312740MOZITPS77 EUDAMED
- EMDN Code
- Z11010492 RADIOTHERAPY TREATMENT PLANNING INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Italy 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
Mozi Tps by Manteia Technologies Co., Ltd. — Class IIb — FDA_510K, MDR — 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/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K223724 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 697312740MOZITPS77 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Manteia Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000023911
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED a69d00b6-653a-4cde-85e7-2ccf917fb7a5 61 fields · synced Jul 9, 2026
- FDA 510(k) K223724 1 fields · synced May 18, 2026