Identity
- Trade Name
- AI4CMR EUDAMED
- Device Name
- AI4CMR EUDAMED
- Model / Reference
- AI4CMR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05600250059039 EUDAMED05600250059015 EUDAMED
- Basic UDI-DI
- 5600250059SW1ZD EUDAMED5600250059SW9U EUDAMED
- Direct Marketing DI
- 05600250059039 EUDAMED05600250059015 EUDAMED
- EMDN Code
- Z12040182 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Portugal 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
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ai4cmr by AI4MedImaging Medical Solutions S.A. — 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 | 5600250059SW1ZD | Class IIa | Active |
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Manufacturer
- Manufacturer
- AI4MedImaging Medical Solutions S.A.
- EUDAMED SRN
- PT-MF-000002951
Sources (2)
- EUDAMED 1357ac4c-a28c-45e2-be8d-0310be07e376 61 fields · synced Jul 18, 2026
- EUDAMED e6862043-d27a-42cf-a8a1-e3f9d43a7d7b 61 fields · synced May 17, 2026