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Comeg Medical

FDA UDI

Class II (US FDA UDI)

by Sopro

Identity

Trade Name
COMEG MEDICAL FDA UDI
Generic Name
Endoscope video camera FDA UDI
Device Name
This camera is a 1CCD color camera, 100% digital, with deported electronic. FDA UDI
Model / Reference
SOPRO 184 CAPTEUR 90° NTSC F15 FDA UDI
Description
This camera is a 1CCD color camera, 100% digital, with deported electronic. FDA UDI

Identifiers

Catalog Number
S_184_8203 FDA UDI
Primary DI / UDI-DI
M430S18482031 FDA UDI
510(k) Number
K082796 FDA UDI
FDA Product Code
GCJ FDA UDI
GMDN Term
Endoscope video camera 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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endoscope video camera

Comeg Medical by Sopro — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscope video camera.

Cleared under the same submission

K082796 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sopro

Sources (1)

  • FDA UDI ee5a8a16-a7b7-4985-b232-3d9ae34f1890 36 fields · synced May 31, 2026