Identity
- Trade Name
- LuxaScope Oculus 2.5V, black edition EUDAMED
- Device Name
- LuxaScope Oculus LED EUDAMED
- Model / Reference
- F1.416.112 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260381965466 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 2.5V, black edition 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 a5beceb8-40a4-4d3f-8116-7dd1f24b0694 61 fields · synced Jul 26, 2026