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LuxaScope Auris LED
EUDAMEDClass I (EU MDR)
Ref A1.416.314Ref A1.416.114Ref A1.416.914Ref A1.426.214Ref A1.416.214Ref A1.516.914Ref A1.426.914Ref A1.426.314Ref A1.416.974Ref A1.426.114Ref A1.416.934Ref A1.616.914Ref A1.416.944
Identity
- Device Name
- LuxaScope Auris LED EUDAMED
- Model / Reference
- A1.416.314 EUDAMEDA1.416.114 EUDAMEDA1.416.914 EUDAMEDA1.426.214 EUDAMEDA1.416.214 EUDAMEDA1.516.914 EUDAMEDA1.426.914 EUDAMEDA1.426.314 EUDAMEDA1.416.974 EUDAMEDA1.426.114 EUDAMEDA1.416.934 EUDAMEDA1.616.914 EUDAMEDA1.416.944 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260381960034 EUDAMED04260381960010 EUDAMED04260381961369 EUDAMED04260381960058 EUDAMED04260381960027 EUDAMED04260381963325 EUDAMED04260381961376 EUDAMED04260381960065 EUDAMED04260381963950 EUDAMED04260381960041 EUDAMED04260381963912 EUDAMED04260381963608 EUDAMED04260381963929 EUDAMED
- Basic UDI-DI
- 426038196OtoskopYN EUDAMED
- EMDN Code
- Z12149006 DIRECT OUTPATIENT OTOSCOPES 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 Auris LED 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 | 426038196OtoskopYN | Class I | Active |
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Manufacturer
- Manufacturer
- Luxamed GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000006437
Sources (13)
- EUDAMED 199da367-3c45-4f7f-a2b9-e715792ce47c 61 fields · synced Oct 6, 2026
- EUDAMED 8ab2f4b0-f0eb-43a7-9aff-27f9aeb6e29f 61 fields · synced May 16, 2026
- EUDAMED 7e83f9ac-5b7c-4a92-8022-03f2b64b6ceb 61 fields · synced May 16, 2026
- EUDAMED 95a50a55-c020-49d8-af81-4a405fe6f01f 61 fields · synced May 17, 2026
- EUDAMED c7e9c122-e6fb-491d-9c3e-7bbe08fc01c2 61 fields · synced May 18, 2026
- EUDAMED 95be5736-4bd2-42b9-9b4b-6febfb6ef520 61 fields · synced May 18, 2026
- EUDAMED 0b0fbddc-50ba-44f2-b35a-55f732fbb583 61 fields · synced May 18, 2026
- EUDAMED cad8ccdb-1b8f-4816-8367-d08745420704 61 fields · synced May 18, 2026
- EUDAMED b9f60cf0-b7fc-4e95-b049-47ed5f203a59 61 fields · synced May 18, 2026
- EUDAMED 30e56b53-85bf-4782-8227-56f971f3656d 61 fields · synced May 18, 2026
- EUDAMED be6911e9-6ede-4ca9-ab20-c7ec47df3d27 61 fields · synced May 18, 2026
- EUDAMED 814fe3ee-f594-40e3-9301-c8a3d3c4811c 61 fields · synced May 18, 2026
- EUDAMED b7b3ceb0-0ab1-45c1-8860-e44349bc1377 61 fields · synced May 19, 2026