Identity
- Trade Name
- OTOLUX-LED EUDAMEDOTOPRONT FDA UDI
- Generic Name
- Endoscopic light source unit, battery-powered FDA UDI
- Device Name
- LED Handheld Light Source EUDAMED
- Model / Reference
- OTOLUX-LED EUDAMEDFDA UDI780012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260154546731 EUDAMEDFDA UDI
- Basic UDI-DI
- 426015454OTLUX2021211033S EUDAMED
- FDA Product Code
- KYT FDA UDI
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
- GMDN Term
- Endoscopic light source unit, battery-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6350 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endoscopic light source unit, battery-powered
Otopront by Happersberger Otopront GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Happersberger Otopront GmbH
Sources (2)
- FDA UDI 6a8fb466-7391-489f-9db6-c9c7155c87f1 32 fields · synced Jun 20, 2026
- EUDAMED 4ca59269-5fa3-47fc-883e-a40bb68c28fb 61 fields · synced Jun 20, 2026