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Light Cable
EUDAMEDFDA UDIClass I (EU MDR)
Ref 242389Model Fiber-Optic Light Guide
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Fibreoptic light cable FDA UDI
- Device Name
- Light Cable EUDAMEDLIGHT GUIDE, UNIVERSAL 3.5MM X 3.0M FDA UDI
- Model / Reference
- Fiber-Optic Light Guide EUDAMED242389 EUDAMEDFDA UDI
- Description
- LIGHT GUIDE, UNIVERSAL 3.5MM X 3.0M FDA UDI
Identifiers
- Catalog Number
- 242389 FDA UDI
- Primary DI / UDI-DI
- 10886705028856 EUDAMEDFDA UDI
- Basic UDI-DI
- 0886705a00011JU EUDAMED
- Direct Marketing DI
- 10886705028856 EUDAMED
- 510(k) Number
- K901035 FDA UDI
- FDA Product Code
- FST FDA UDI
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
- GMDN Term
- Fibreoptic light cable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4580 FDA UDI
- Market of Registration
- Belgium 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endoscopic light source unit, line-powered
Light Cable by Medos International Sarl — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Endoscopic light source unit, line-powered.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0886705a00011JU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medos International SARL
- EUDAMED SRN
- CH-MF-000014268
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (2)
- EUDAMED c28fad6c-353b-4f66-96fd-aca15e17f97f 61 fields · synced Jul 14, 2026
- FDA UDI 8195c33b-1da3-4d7e-b3c8-0580c5e93736 36 fields · synced May 30, 2026