Identity
- Trade Name
- EVERLUX FDA UDI
- Generic Name
- General-purpose light source FDA UDI
- Device Name
- EVERLUX LIGHT SOURCE FDA UDI
- Model / Reference
- R02 FDA UDI
- Description
- EVERLUX LIGHT SOURCE FDA UDI
Identifiers
- Catalog Number
- U1LED100C03 FDA UDI
- Primary DI / UDI-DI
- B366U1LED100C03 FDA UDI
- FDA Product Code
- EQH FDA UDI
- GMDN Term
- General-purpose light source FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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: General-purpose light source
Everlux by Ecleris — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose light source.
- Integra® — Integra LifeSciences Production Corporation · Class II
- Orascoptic - Endeavour TruColor Headlight System — METREX RESEARCH · Class I
- BR Surgical, LLC — BR SURGICAL LLC · Class II
- NICO Myriad-LX — NICO Corporation · Class II
- Integra® — Integra LifeSciences Production Corporation · Class II
- Orascoptic - Endeavour TruColor Headlight System — METREX RESEARCH · Class I
- Integra® — INTEGRA LIFESCIENCES (IRELAND) LIMITED · Class II
- Orascoptic - Endeavour TruColor XL Headlight System — METREX RESEARCH · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ecleris
Sources (1)
- FDA UDI 3e32733c-b064-4849-a286-485e32f116af 36 fields · synced May 30, 2026