FDA.reportPublic FDA data

UNOMEDICAL S.R.O.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30057784703005778470UNOMEDICAL S.R.O.1N2026-01-01PRIEMYSELNY PARK 3 MICHALOVCE Kosicky SK 07101

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3347121081320490K232665GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)EZD2024-01-25
3347121763827780K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterGBM2022-06-22
3347121273045649K181206GentleCath Glide Intermittent Urinary CatheterGBM2018-08-16
3347121192756328
3347121554131193
3347121659894410
3347121777559758
3347121816367477

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GBM22022-06-22
EZD12024-01-25