Identity
- Device Name
- iCare RETCAD EUDAMED
- Model / Reference
- iCare RETCAD EUDAMEDRRTCPRM000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053677040529 EUDAMED
- Basic UDI-DI
- 805367704DiagnosticAI22 EUDAMED
- Direct Marketing DI
- 08053677040529 EUDAMED
- EMDN Code
- Z12129092 VARIOUS OPHTALMOLOGY 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
iCare RETCAD by Centervue S.p.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 | 805367704DiagnosticAI22 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Centervue S.p.a.
- EUDAMED SRN
- IT-MF-000017082
Sources (1)
- EUDAMED 321f1bb0-9aa6-4276-ae37-e4a6eb06f2f3 61 fields · synced Jul 10, 2026