← Back to catalogue

Comeg Medical Technologies

FDA UDI

Class I (US FDA UDI)

by Sopro

Identity

Trade Name
COMEG MEDICAL TECHNOLOGIES FDA UDI
Generic Name
Endoscope video camera FDA UDI
Device Name
A TURNKEY SOLUTION FOR CONSULTING ROOM DIAGNOSTICS AND TREATMENT UBIPack brings surgeons the perfect all-in-one tool for diagnosis and treatment in an office setting. FDA UDI
Model / Reference
UBIPACK ENT SYSTEM FDA UDI
Description
A TURNKEY SOLUTION FOR CONSULTING ROOM DIAGNOSTICS AND TREATMENT UBIPack brings surgeons the perfect all-in-one tool for diagnosis and treatment in an office setting. FDA UDI

Identifiers

Catalog Number
SK101016 FDA UDI
Primary DI / UDI-DI
03760278260045 FDA UDI
510(k) Number
K103813 FDA UDI
FDA Product Code
FWF FDA UDI
NTN FDA UDI
FCW FDA UDI
GMDN Term
Endoscope video camera FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4160 FDA UDI
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

Yes

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: Endoscopic light source unit, line-poweredEndoscope video camera

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

Similar devices

Also classified as Endoscope video camera.

Cleared under the same submission

K103813 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Sopro

Sources (1)

  • FDA UDI 086813ac-bde5-4f70-94de-a88c218c68e3 36 fields · synced May 30, 2026