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LuxaScope Auris LED Set Otoskop 2.5V und Diagnostikleuchte BLACK EDITION
EUDAMEDClass I (EU MDR)
Ref AE.416.114
Identity
- Trade Name
- LuxaScope Auris LED Set Otoskop 2.5V und Diagnostikleuchte BLACK EDITION EUDAMED
- Device Name
- LuxaScope Auris LED EUDAMED
- Model / Reference
- AE.416.114 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260381965091 EUDAMED
- Basic UDI-DI
- 426038196OtoskopYN EUDAMED
- Direct Marketing DI
- 04260381965091 EUDAMED
- EMDN Code
- Z12149006,Z129004 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 Set Otoskop 2.5V und Diagnostikleuchte BLACK EDITION by Luxamed GmbH & Co. KG — Class I — MDR — listed in EUDAMED
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 35c775e4-cdf4-4602-8143-f5c562de5484 61 fields · synced Oct 6, 2026