Identity
- Trade Name
- LIGHT SOURCES EUDAMEDEVERLUX LIGHT SOURCE FDA UDI
- Generic Name
- General-purpose light source FDA UDI
- Device Name
- EVERLUX LIGHT SOURCE EUDAMEDFDA UDI
- Model / Reference
- U1LED100G2/1 EUDAMEDLED100G2/1 EUDAMEDR00 FDA UDI
- Description
- EVERLUX LIGHT SOURCE FDA UDI
Identifiers
- Catalog Number
- U1LED100G21 FDA UDI
- Primary DI / UDI-DI
- B366U1LED100G21 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B366U1EVERLUXG29F EUDAMED
- Direct Marketing DI
- B366U1LED100G21 EUDAMED
- FDA Product Code
- NTN FDA UDI
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
- GMDN Term
- General-purpose light source FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Italy 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
No
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
Yes
FDA UDI
Category: Endoscopic light source unit, line-powered
Light Sources by EUSA Global Llc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | ++B366U1EVERLUXG29F | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- EUSA Global Llc.
- EUDAMED SRN
- US-MF-000003607
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED f7596857-c596-44ae-ac3d-7075891a9971 61 fields · synced Jul 14, 2026
- FDA UDI b11204ec-57aa-41c1-b882-22874338eea3 36 fields · synced May 25, 2026