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RetinAI Macula Biomarkers
EUDAMEDClass IIa (EU MDR)
Ref 7640486841167
by Ikerian AG
Identity
- Trade Name
- RetinAI Macula Biomarkers EUDAMED
- Device Name
- RetinAI Macula Biomarkers EUDAMED
- Model / Reference
- 7640486841167 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640486841167 EUDAMED
- Basic UDI-DI
- 764048684Biomarker20043SV EUDAMED
- EMDN Code
- Z12120192 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Austria 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
RetinAI Macula Biomarkers by Ikerian AG — 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 | 764048684Biomarker20043SV | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ikerian AG
- EUDAMED SRN
- CH-MF-000014537
- Authorised Representative
- Blue Broccoli GmbH LI-AR-000000233
Sources (1)
- EUDAMED 89d0d6f8-0b53-4cd1-af0c-ba4a7c0b8ea1 61 fields · synced Jun 18, 2026