BRIGHT URO, INC.

FDA Device Registration & Listing · Irvine, CA, US · Registration 3029753827

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3029753827
FEI Number
3029753827
Entity Name
BRIGHT URO, INC.
City/State/Country
Irvine, CA, US
Establishment Address
3 Goddard, Irvine, CA 92618, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Bright Uro, Inc. (Owner Number: 10093586)
Owner / Operator Contact Address
3 Goddard, Irvine, CA 92618, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K253537
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EXQ Cystometer, Electrical Recording Gastroenterology, Urology Class 2 876.1620 2025-06-09
EXY Uroflowmeter Gastroenterology, Urology Class 2 876.1800 2025-06-09
EXY Uroflowmeter Gastroenterology, Urology Class 2 876.1800 2026-04-20
EXQ Cystometer, Electrical Recording Gastroenterology, Urology Class 2 876.1620 2026-04-20

Official Correspondent

Suranjan Roychowdhury

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Bright Uro, 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 3029753827. Last updated year: 2026. Please use registration number 3029753827 when referencing this establishment in official correspondence.
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