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RetinAI OCT Atlas
EUDAMEDClass IIa (EU MDR)
Ref 7640486840030Model OCT Atlas 4.0.0
by Ikerian AG
Identity
- Trade Name
- RetinAI OCT Atlas EUDAMED
- Device Name
- RetinAI OCT Atlas EUDAMED
- Model / Reference
- OCT Atlas 4.0.0 EUDAMED7640486840030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640486840030 EUDAMED
- Basic UDI-DI
- 764048684OCTATLAS4142DX EUDAMED
- EMDN Code
- Z12120192 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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 OCT Atlas 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 | 764048684OCTATLAS4142DX | 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 1877ce84-19ba-4215-a0eb-467fbc7b4b91 61 fields · synced Jul 10, 2026