FDA.reportPublic FDA data

CONVATEC DOMINICAN REPUBLIC, INC.

Matched from indexed company URL: CONVATEC INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96180033003264198CONVATEC DOMINICAN REPUBLIC, INC.1N2026-01-01CARRETERA SANCHEZ, KM. 18.5 PARQUE INDUSTRIAL ITABO, S.A., Buildings 8A, 23, Haina San Cristobal DO 91000
10003175711000317571CONVATEC LIMITED1N2026-01-01First Avenue DEESIDE INDUSTRIAL PARK Deeside Flintshire GB CH5 2NU
30088068093008806809ConvaTec Limited, GDC Building1N2026-01-01First Avenue Deeside Industrial Park Deeside Flintshire GB CH5 2NU
30119879673011987967ConvaTec, Inc.1Y2026-01-017815 National Service Road Suite 600 Greensboro NC US 27409
30128817403012881740ConvaTec Canada Ltd.1N2026-01-011425 TransCanada Highway Suite 100 Dorval Quebec CA H9P 2V3
30176607503017660750CONVATEC TRIAD LIFE SCIENCES, LLC1N2026-01-011770 Moriah Woods Blvd. Suite 18 Memphis TN US 38117

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
00768455108268STOMAHESIVE - Stomahesive® Protective Powder, 1 Oz.+18004228811cic12@convatec.com
00768455201303AVELLE - Avelle™ Negative Pressure Wound Therapy Carry Bag1-800-422-8811cic@convatec.com
00768455204670ESTEEM - N/A+18004228811cic12@convatec.com
00768455204717ESTEEM - N/A+18004228811cic12@convatec.com
00768455204724ESTEEM - N/A+18004228811cic12@convatec.com
00768455204748ESTEEM - N/A+18004228811cic12@convatec.com
00768455204755ESTEEM - N/A+18004228811cic12@convatec.com
00768455204762ESTEEM - N/A+18004228811cic12@convatec.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1144441223202219K973076EUROMEDICAL HAEMATURIA FOLEY CATHETEREZL1998-09-16
1860471223202219K973076EUROMEDICAL HAEMATURIA FOLEY CATHETEREZL1998-09-16
1860471902702130K965120ALLCLENZ WOUND CLEANSERKMF1997-03-21
1144441113729483K962389EUROMEDICAL REINFORCED ENDOTRACHEAL TUBEBTR1996-11-21
1860471113729483K962389EUROMEDICAL REINFORCED ENDOTRACHEAL TUBEBTR1996-11-21
1144442016582059K954752PEDIATRIC EUROPHYLIC FOLEY CATHETEREZL1995-10-30
1860472016582059K954752PEDIATRIC EUROPHYLIC FOLEY CATHETEREZL1995-10-30
1144442001848651K951697PEDIATRIC ENDOTRACHEAL TUBEBTR1995-05-22
1860472001848651K951697PEDIATRIC ENDOTRACHEAL TUBEBTR1995-05-22
1144441802119416K951696ENDOTRACHEAL TUBEBTR1995-05-22
1860471802119416K951696ENDOTRACHEAL TUBEBTR1995-05-22
1144441226586775K945874EUROMEDICAL POLY TRACHEOTOMY TUBEJOH1994-12-27
1860471226586775K945874EUROMEDICAL POLY TRACHEOTOMY TUBEJOH1994-12-27
1144441668174056K945806SILICATH ALL SILICONE FOLEY CATHETEREZL1995-03-21
1860471668174056K945806SILICATH ALL SILICONE FOLEY CATHETEREZL1995-03-21
1144441459039740K944007EUROPHILIC SLIPPERY COATED FOLEY CATHETEREZL1995-06-29
1860471459039740K944007EUROPHILIC SLIPPERY COATED FOLEY CATHETEREZL1995-06-29
1144441217228519K915750DISPOSABLE BACTERIAL BREATHNG FILTERCAH1994-11-30
1860471217228519K915750DISPOSABLE BACTERIAL BREATHNG FILTERCAH1994-11-30
1144441684368274K915228DISPOSABLE CO2 GAS SAMPLING/OXYGEN DELIVERY CANNULCCK1992-02-11
1860471684368274K915228DISPOSABLE CO2 GAS SAMPLING/OXYGEN DELIVERY CANNULCCK1992-02-11
1144442054476910K896734FEEDING TUBEFPD1990-12-21
1860472054476910K896734FEEDING TUBEFPD1990-12-21
1144441554131193K896729NELATON-, FEMALE - OR TIEMANN CATHETERKOD1990-11-05
1860471554131193K896729NELATON-, FEMALE - OR TIEMANN CATHETERKOD1990-11-05
1144441109876878K874517PHARMASEAL RUBBER URETHRAL CATHETERKOD1987-12-03
1860471109876878K874517PHARMASEAL RUBBER URETHRAL CATHETERKOD1987-12-03
1144441374029343K873286DISPOSABLE, MANUAL PULMONARY RESUSCITATORBTM1987-10-26
1860471374029343K873286DISPOSABLE, MANUAL PULMONARY RESUSCITATORBTM1987-10-26
361871897993971K862935WOUND MANAGER(TM) - STERILENAD1986-08-20
1144441897993971K862935WOUND MANAGER(TM) - STERILENAD1986-08-20
1860471897993971K862935WOUND MANAGER(TM) - STERILENAD1986-08-20
1144441519889704K842395SUR-FIT NIGHT DRAINAGE CONTAINER SETKNX1984-08-08
1860471519889704K842395SUR-FIT NIGHT DRAINAGE CONTAINER SETKNX1984-08-08
1144441226737647K841544AMER. PHARMASEAL SILICONIZED LATEXKOD1984-07-09
1860471226737647K841544AMER. PHARMASEAL SILICONIZED LATEXKOD1984-07-09
361861395607584K832299VISI-FLOW IRRIGATOREXD1983-08-26
1144441395607584K832299VISI-FLOW IRRIGATOREXD1983-08-26
1860471395607584K832299VISI-FLOW IRRIGATOREXD1983-08-26
361861980085316K811240SUR-FIT LOOP OSTOMY O.R. SETEXB1981-06-16
361871980085316K811240SUR-FIT LOOP OSTOMY O.R. SETEXB1981-06-16
1144441980085316K811240SUR-FIT LOOP OSTOMY O.R. SETEXB1981-06-16
1860471980085316K811240SUR-FIT LOOP OSTOMY O.R. SETEXB1981-06-16
361861531848327K811239SUR-FIT DISPOSABLE CONVEX INSERTEXB1981-06-09
1144441531848327K811239SUR-FIT DISPOSABLE CONVEX INSERTEXB1981-06-09
1860471531848327K811239SUR-FIT DISPOSABLE CONVEX INSERTEXB1981-06-09
361861565691994K811160SUR-FIT IRRIGATION SLEEVEEXD1981-06-02
1144441565691994K811160SUR-FIT IRRIGATION SLEEVEEXD1981-06-02
1860471565691994K811160SUR-FIT IRRIGATION SLEEVEEXD1981-06-02
361861036121330K810200OPTIPORE SCRUB SPONGEEFQ1981-02-13
1144441036121330K810200OPTIPORE SCRUB SPONGEEFQ1981-02-13
1860471036121330K810200OPTIPORE SCRUB SPONGEEFQ1981-02-13
1144441206633653K791536DISPOSABLE MEDICATION NEBULIZERCAF1979-09-07
1860471206633653K791536DISPOSABLE MEDICATION NEBULIZERCAF1979-09-07
1144441742284325K770256CATHETERS, SILICONE COATEDKOD1977-02-17
1860471742284325K770256CATHETERS, SILICONE COATEDKOD1977-02-17
1144441531414218K760372HUMIDIFIER, DISPOSABLEBTT1976-08-13
1860471531414218K760372HUMIDIFIER, DISPOSABLEBTT1976-08-13
1144441554320926K260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).EZD2026-08-05
1860471554320926K260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).EZD2026-08-05
1144441481946500K252943GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for WomenEZD2026-04-01
1144441179686771K250891Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14CFCM2025-06-06
1860471179686771K250891Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14CFCM2025-06-06
1144441191079854K250699Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K)EZD2025-07-01
1860471191079854K250699Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K)EZD2025-07-01
361861635474744K243228Flexi-Seal AIR (with ENFit Connector)KNT2025-03-28
1144441635474744K243228Flexi-Seal AIR (with ENFit Connector)KNT2025-03-28
1860471635474744K243228Flexi-Seal AIR (with ENFit Connector)KNT2025-03-28
1144441081320490K232665GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)EZD2024-01-25
1860471081320490K232665GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)EZD2024-01-25
361871808274185K230400Cure Catheter Closed System; Cure Dextra Closed SystemEZD2023-11-08
1860471808274185K230400Cure Catheter Closed System; Cure Dextra Closed SystemEZD2023-11-08
361871757976397K221593Cure Ultra Male, Cure Ultra Female, Cure Ultra PlusEZD2022-11-17
1860471757976397K221593Cure Ultra Male, Cure Ultra Female, Cure Ultra PlusEZD2022-11-17
2836811069931369K213716InnovaBurnKGN2022-09-29
1144441763827780K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterGBM2022-06-22
1860471763827780K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterGBM2022-06-22
2836811960655089K211902InnovaMatrix PDKGN2022-09-28
2836811648931872K210580InnovaMatrix FSKGN2021-04-21
2836811807949189K193552InnovaMatrixKGN2020-10-21
361861623990277K190114Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)KNT2019-04-30
361871623990277K190114Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)KNT2019-04-30
1144441623990277K190114Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)KNT2019-04-30
1860471623990277K190114Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)KNT2019-04-30
1997261623990277K190114Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)KNT2019-04-30
1144441273045649K181206GentleCath Glide Intermittent Urinary CatheterGBM2018-08-16
1860471273045649K181206GentleCath Glide Intermittent Urinary CatheterGBM2018-08-16
1144441687694772K180205AVELLE Negative Pressure Wound Therapy SystemOMP2018-10-19
1860471687694772K180205AVELLE Negative Pressure Wound Therapy SystemOMP2018-10-19
361871000402544K173675AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening FiberFRO2018-07-20
1144441000402544K173675AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening FiberFRO2018-07-20
1860471000402544K173675AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening FiberFRO2018-07-20
1144441816367477K172924GentleCath Intermittent Urinary CatheterKOD2017-11-21
1860471816367477K172924GentleCath Intermittent Urinary CatheterKOD2017-11-21
361862005630600K162906Flexi-Seal PROTECT Fecal Management SystemKNT2017-03-07
361872005630600K162906Flexi-Seal PROTECT Fecal Management SystemKNT2017-03-07
1144442005630600K162906Flexi-Seal PROTECT Fecal Management SystemKNT2017-03-07
1860472005630600K162906Flexi-Seal PROTECT Fecal Management SystemKNT2017-03-07
1997262005630600K162906Flexi-Seal PROTECT Fecal Management SystemKNT2017-03-07
361871777559758K161344GentleCath Glide Intermittent CatheterKOD2016-09-20
1144441777559758K161344GentleCath Glide Intermittent CatheterKOD2016-09-20
1860471777559758K161344GentleCath Glide Intermittent CatheterKOD2016-09-20
361861747996319K152926AQUACEL Ag Surgical SP DressingFRO2016-01-21
1144441747996319K152926AQUACEL Ag Surgical SP DressingFRO2016-01-21
1860471747996319K152926AQUACEL Ag Surgical SP DressingFRO2016-01-21
361861945556625K150350Flexi-Seal Signal Fecal Management SystemKNT2015-07-21
361871945556625K150350Flexi-Seal Signal Fecal Management SystemKNT2015-07-21
1144441945556625K150350Flexi-Seal Signal Fecal Management SystemKNT2015-07-21
1860471945556625K150350Flexi-Seal Signal Fecal Management SystemKNT2015-07-21
1997261945556625K150350Flexi-Seal Signal Fecal Management SystemKNT2015-07-21
1144441449037304K132500CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATEDEZD2013-12-23
1860471449037304K132500CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATEDEZD2013-12-23
361871516537495K123481AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVEFRO2013-06-06
1144441516537495K123481AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVEFRO2013-06-06
1860471516537495K123481AQUACEL 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
1144441114474239K121275AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBERFRO2012-07-25

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FRO272018-07-20
KNT252025-03-28
EZD202026-08-05
KOD152017-11-21
EZL81998-09-16
EXB71981-06-16
BTR61996-11-21
EXD61983-08-26
KGN42022-09-29
GBM42022-06-22
FCM32025-06-06
NAD31986-08-20
EFQ31981-02-13
OMP22018-10-19
FPA22012-04-20
JOH21994-12-27
CAH21994-11-30
CCK21992-02-11
FPD21990-12-21
BTM21987-10-26
KNX21984-08-08
CAF21979-09-07
BTT21976-08-13
KMF11997-03-21

PMN#

119 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next