Unity 9100

FDA UDI

Class II (US FDA UDI)

by Cogentix Medical, Inc.

Identity

Trade Name: UNITY 9100 FDA UDI
Generic Name: Endoscopic video image processing unit FDA UDI
Device Name: UNITY 9100 Video Processor with Air Pump for use with Cogentix Medical video endoscopes FDA UDI
Model / Reference: UVP-9100 FDA UDI
Description: UNITY 9100 Video Processor with Air Pump for use with Cogentix Medical video endoscopes FDA UDI

Identifiers

Primary DI / UDI-DI: 00874485003210 FDA UDI
510(k) Number: K181292 FDA UDI
FDA Product Code: OCS FDA UDI
EOQ FDA UDI
FAJ FDA UDI
EOX FDA UDI
EOB FDA UDI
GMDN Term: Endoscopic video image processing unit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
874.4680 FDA UDI
874.4710 FDA UDI
874.4760 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Endoscopic video image processing unit

Unity 9100 by Cogentix Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic video image processing unit.

Pixa — SANTA BARBARA IMAGING SYSTEMS, INC. · Class II
ILO — ILO electronic GmbH · Class I
AURORA® Surgiscope® — Integra Lifesciences Corp. · Class II
VIDEO PROCESSOR — PENTAX of America, Inc. · Class II
Digital Video Processor — Hunan Vathin Medical Instrument Co., Ltd · Class II
ILO — ILO electronic GmbH · Class I
3NT Video Console — 3nt Medical , Ltd. · Class II
HDMI cable — MacroLux Medical Technology Co., Ltd. · Class II

Cleared under the same submission

K181292 also covers:

UNITY 9000 — COGENTIX MEDICAL, INC.

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: Cogentix Medical, Inc.

Sources (1)

FDA UDI 6383cd4b-c08a-4451-ae28-c9885204dba4 34 fields · synced Jun 8, 2026