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Otoskop&Ophthalmoskop Diagnostik Set 2.5V, KIDS
EUDAMEDClass I (EU MDR)
Ref AF.516.914
Identity
- Trade Name
- Otoskop&Ophthalmoskop Diagnostik Set 2.5V, KIDS EUDAMED
- Device Name
- LuxaScope Auris LED EUDAMED
- Model / Reference
- AF.516.914 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260381964537 EUDAMED
- Basic UDI-DI
- 426038196OtoskopYN EUDAMED
- EMDN Code
- Z12120114,Z12149006 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
Otoskop&Ophthalmoskop Diagnostik Set 2.5V, KIDS 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 (1)
- EUDAMED 30d80155-938e-4838-9f9b-5e276bc20ebc 61 fields · synced Oct 8, 2026