Identity
- Device Name
- ART.1 EUDAMED
- Model / Reference
- ART.1 EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09361659000003 EUDAMED
- Basic UDI-DI
- 93616590DoseReviewV5 EUDAMED
- EMDN Code
- Z119092 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa 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
Art.1 by SeeTreat Pty Ltd — Class IIa — 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 | 93616590DoseReviewV5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- SeeTreat Pty Ltd
- EUDAMED SRN
- AU-MF-000045001
- Authorised Representative
- Qualrep Services B.V. NL-AR-000000537
Sources (1)
- EUDAMED 5899ce9d-46dd-497e-936d-2035ca6bb13c 61 fields · synced Jul 9, 2026