Identity
- Trade Name
- LuxaScope Oculus EUDAMED
- Device Name
- LuxaScope Oculus LED EUDAMED
- Model / Reference
- F1.416.954 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260381964407 EUDAMED
- Basic UDI-DI
- 426038196OphthalmoskopZH EUDAMED
- EMDN Code
- Z12120114 OPHTHALMOSCOPES EUDAMED
Classification
- Device Class
- Class I 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
LuxaScope Oculus by Luxamed GmbH & Co. KG — Class I — 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 | 426038196OphthalmoskopZH | Class I | Active |
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Manufacturer
- Manufacturer
- Luxamed GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000006437
Sources (1)
- EUDAMED c440caec-38ed-4d40-8ce7-a35aff934384 61 fields · synced Jun 18, 2026