Identity
- Trade Name
- LuxIA EUDAMED
- Device Name
- LuxIA EUDAMED
- Model / Reference
- 7640486841211 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640486841211 EUDAMED
- Basic UDI-DI
- 764048684Luxia20101BE EUDAMED
- EMDN Code
- Z12120192 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- Software 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
LuxIA by Ikerian AG — Class IIb — 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 | 764048684Luxia20101BE | Class IIb | 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 6d6c9951-b0db-4ff8-9625-b46dd8205108 61 fields · synced Jun 19, 2026