Identity
- Trade Name
- COMEG MEDICAL FDA UDI
- Generic Name
- Endoscopic light source unit, line-powered FDA UDI
- Device Name
- "SYMBIOZ LED is a LED light source intended to be used by doctors during surgical endoscopy or diagnostic procedures. It is fitted with an electronic iris with fibre optic detection, an automatic thermal protection system, a powerful level memory and an «iris» mode to shut off the light emission." FDA UDI
- Model / Reference
- SOURCE LED SOPRO S298 FDA UDI
- Description
- "SYMBIOZ LED is a LED light source intended to be used by doctors during surgical endoscopy or diagnostic procedures. It is fitted with an electronic iris with fibre optic detection, an automatic thermal protection system, a powerful level memory and an «iris» mode to shut off the light emission." FDA UDI
Identifiers
- Catalog Number
- S_298_0002 FDA UDI
- Primary DI / UDI-DI
- M430S29800021 FDA UDI
- FDA Product Code
- NTN FDA UDI
- GMDN Term
- Endoscopic light source unit, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
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
Yes
FDA UDI
Category: Endoscopic light source unit, line-powered
Comeg Medical by Sopro — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic light source unit, line-powered.
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- Endoscope Light Source — Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Class I
- SL-EL200 — SONOSCAPE MEDICAL CORP. · Class IIa
- LED 610 Light source — Erbe Vision GmbH · Class I
- SPOTLIGHT — Depuy Spine, Inc. · Class II
- SL-ED10 — SONOSCAPE MEDICAL CORP. · Class I
- FUJIFILM — FUJIFILM Corporation · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Sopro
Sources (1)
- FDA UDI b2d76099-6f73-4f2b-93f7-6effb81e13da 35 fields · synced May 29, 2026