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UROVIU CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30150422093015042209UROVIU CORPORATION1N2026-01-014546 El Camino Real Suite 214 Los Altos CA US 94022

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860008483706Uro-G Flexible Cystoscope - The Uro-G Flexible Cystoscope System consists of a multi-use handle with an LCD screen and a single-use sterile cannula. The Uro-G Flexible Cystoscope is intended for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra.650 397 5174cs@uroviu.com
00860008483713Uro-V Cystoscope - The Uro-V cystoscope system consists of a multi-use handle with an LCD screen and a single-use cannula. The system is used for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra.650 397 5174cs@uroviu.com
00860008483720Uro-N Cystoscope - The Uro-N cystoscope system consists of a mulit-use handle with an LCD screeen and a single-use sterile cannula. The Uro-N is intended fr directed injection of therapeutic agents and solutions into target areas of the bladder and the lower urinary tract via a cystoscope.650 397 5174cs@uroviu.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2227081884715819K253226UV5000W HandleFAJ2025-10-23
2227081739462515K250797UV5000 HandleFAJ2025-09-11
2227081057068142K232837Uro-G HD Flexible CystoscopeFAJ2024-06-07
2227082066500138K202921Uro-G CystoscopeFAJ2021-05-04
2227081544998389K202445Hystero-V HysteroscopeHIH2021-11-23
2227081025073528K182876Uro-N CystoscopeFAJ2019-07-02
2227081049458926K171500Uro-V CystoscopeFAJ2018-01-30
2227081114287020
2227081424320998

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FAJ72025-10-23
HIH12021-11-23

PMN#

GUDID#