Identity
- Trade Name
- iCare MAIA EUDAMED
- Device Name
- MAIA EUDAMED
- Model / Reference
- AHMACME001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053677040130 EUDAMED
- Basic UDI-DI
- 805367704MicroPerimeterRM EUDAMED
- Direct Marketing DI
- 08053677040130 EUDAMED
- EMDN Code
- Z1212012003 PERIPHERAL VISION ANALYSERS EUDAMED
Classification
- Device Class
- Class IIa 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
iCare MAIA by Centervue S.p.a. — Class IIa — 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 | K243504 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 805367704MicroPerimeterRM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Centervue S.p.a.
- EUDAMED SRN
- IT-MF-000017082
Sources (2)
- EUDAMED 032eafa0-2e06-4f88-b4d1-244c3364d0c5 85 fields · synced Jun 18, 2026
- FDA 510(k) K243504 1 fields · synced May 18, 2026