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LuxaScope Oculus
EUDAMEDClass I (EU MDR)
Ref F1.416.964Ref F1.426.114Ref F1.516.914Ref F1.416.914Ref F1.416.974
Identity
- Trade Name
- LuxaScope Oculus EUDAMED
- Device Name
- LuxaScope Oculus LED EUDAMED
- Model / Reference
- F1.416.964 EUDAMEDF1.426.114 EUDAMEDF1.516.914 EUDAMEDF1.416.914 EUDAMEDF1.416.974 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260381964414 EUDAMED04260381964339 EUDAMED04260381964520 EUDAMED04260381964322 EUDAMED04260381964421 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 (5)
- EUDAMED 733e867c-3e2d-4b84-9ac6-b063d21f9b15 61 fields · synced Jul 30, 2026
- EUDAMED 66b56675-334d-4d79-969c-80a1286151a3 61 fields · synced May 17, 2026
- EUDAMED 218dcdab-c2af-44f4-984e-0aa49267b69c 61 fields · synced May 17, 2026
- EUDAMED 901622b9-cfec-40a1-8ee2-00eedb85f44a 61 fields · synced May 17, 2026
- EUDAMED c94b6170-5f3f-48c1-b964-589059b20341 61 fields · synced May 18, 2026