FDA.reportPublic FDA data

CONVATEC LIMITED

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10003175711000317571CONVATEC LIMITED1N2026-01-01First Avenue DEESIDE INDUSTRIAL PARK Deeside Flintshire GB CH5 2NU

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
361871897993971K862935WOUND MANAGER(TM) - STERILENAD1986-08-20
361871980085316K811240SUR-FIT LOOP OSTOMY O.R. SETEXB1981-06-16
361871808274185K230400Cure Catheter Closed System; Cure Dextra Closed SystemEZD2023-11-08
361871757976397K221593Cure Ultra Male, Cure Ultra Female, Cure Ultra PlusEZD2022-11-17
361871623990277K190114Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)KNT2019-04-30
361871000402544K173675AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening FiberFRO2018-07-20
361872005630600K162906Flexi-Seal PROTECT Fecal Management SystemKNT2017-03-07
361871777559758K161344GentleCath Glide Intermittent CatheterKOD2016-09-20
361871945556625K150350Flexi-Seal Signal Fecal Management SystemKNT2015-07-21
361871516537495K123481AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVEFRO2013-06-06
361871114474239K121275AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBERFRO2012-07-25
361871995193648K112342FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEMKNT2012-04-26
361871844093946K090254SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT)FRO2009-09-04
361871693345941K080383AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSINGFRO2008-05-02
361871518845498K063271AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED ANTIMICROBIAL DRESSINGFRO2007-04-16
361872054505273K013814ABSORBENT ANTIMICROBIAL WOUND DRESSINGFRO2002-06-21
361871372449025
361871164774439
361871192756328
361871258268498
361871350933909
361871362325805
361871426895164
361871436005302
361871466573805
361871659894410
361871663679583
361871897973508
361871975863957
361872035535473
361872040660236

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FRO72018-07-20
KNT42019-04-30
EZD22023-11-08
KOD12016-09-20
NAD11986-08-20
EXB11981-06-16

PMN#