Identity
- Device Name
- Reti-Eye Reti-CVD EUDAMED
- Model / Reference
- DrNoon EUDAMEDIFU-DN-CE-05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18800118000010 EUDAMED
- Basic UDI-DI
- 88001180RetiAI68 EUDAMED
- Direct Marketing DI
- 18800118000010 EUDAMED
- EMDN Code
- Z129092 VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa 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
Reti-Eye Reti-CVD by Mediwhale, Inc — 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 | 88001180RetiAI68 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Mediwhale, Inc
- EUDAMED SRN
- KR-MF-000011626
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED 79ca24a5-fe17-4c21-a4c0-ff2eb04066f5 61 fields · synced Jul 19, 2026