FDA.reportPublic FDA data

URAMIX, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
25314753001642379URAMIX, INC.1N2026-01-01272 N. LANSDOWNE AVE. E Lansdowne PA US 19050

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
542441434305623K240374
542442058997950K231118Cystoscope SystemFAJ2023-11-13
542441834264600K223448Bladder Scanner Model: BVT02IYO2023-07-07
542441169177819K203141Uramix CuraWay Biopsy NeedleKNW2021-09-17
542441203678665
542441526480441
542441532521250
542441537055700
542441548519122
542441564563416
542441784136090
542441934907572
542441960652249
542441962744179
542442017625027
542442073241462
542442073384373

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FAJ12023-11-13
IYO12023-07-07
KNW12021-09-17

PMN#