Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005105203

FEI Number

3005105203

Entity Name

OMNI MEASUREMENT SYSTEMS, INC.

City/State/Country

Colchester, VT, US

Establishment Address

808 Hercules Drive, Colchester, VT 05446, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

OMNI MEASUREMENT SYSTEMS, INC. (Owner Number: 9095703)

Owner / Operator Contact Address

808 Hercules Drive, Colchester, VT 05446, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SKYDRATE Gen 6 Tactical Pad for Females AMXDmax Integrity URINCARE ProRen Bladder Management System Integrity Gen 6 Tactical Pad for Females URINCARE SKYDRATE ProRen Bladder Management System AMXDmax ProRen Bladder Management System AMXDmax URINCARE SKYDRATE Integrity

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EXI	Device, Paste-On For Incontinence, Sterile	Gastroenterology, Urology	Class 1	876.5250	2014-09-05
NOA	Device, Paste-On For Incontinence, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2014-06-18
NZU	Collector, Urine, Powered, Non Indwelling Catheter	Gastroenterology, Urology	Class 1	876.5250	2006-12-15

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OMNI MEASUREMENT SYSTEMS, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005105203. Last updated year: 2026. Please use registration number 3005105203 when referencing this establishment in official correspondence.