CONVATEC LIMITED

FDA Device Registration & Listing · Deeside Flintshire, GB · Registration 1000317571

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1000317571
FEI Number
1000317571
Entity Name
CONVATEC LIMITED
City/State/Country
Deeside Flintshire, GB
Establishment Address
First Avenue, DEESIDE INDUSTRIAL PARK, Deeside Flintshire CH5 2NU, GB
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ConvaTec (Owner Number: 2241599)
Owner / Operator Contact Address
7815 National Service Road, Suite 600, Greensboro, NC 27409, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

DUODERM HYDROACTIVE GEL SAF-GEL Esenta Stomahesive Protective Powder ESTEEM SYNERGY Durahesive Moldable Convex with Flexible Collar NATURA Stomahesive Moldable NATURA SUR-FIT Durahesive Wafer SUR-FIT Plus Stomahesive Wafer Two-Piece NATURA Durahesive Moldable LITTLE ONES Two Piece Stomahesive with Flexible collar NATURA SUR-FIT Stomahesive Wafer with Flexible Collar NATURA Durahesive Accordion Flange SENSI-CARE Barrier Wipes NATURA SUR-FIT Durahesive Moldable Convex with Flange SUR-FIT Plus Stomahesive Wafer NATURA Stomahesive Accordion Flange AutoLock SUR-FIT Stomahesive FLEXIBLE Wafer ESTEEM SYNERGY Stomahesive ESTEEM SYNERGY Stomahesive Moldable NATURA SUR-FIT Durahesive with Convex-It Wafer with Convexity ESTEEM SYNERGY Stomahesive with Flexible Collar NATURA SUR-FIT Stomahesive Wafer ESENTA Barrier Pump Spray NATURA Durahesive Moldable Accordion Flange LITTLE ONES Two-Piece Adhesive Stomahesive with Flexible Hydrocolloid Collar Stomahesive Paste EASE Strips ESENTA Barrier Spray ESENTA Barrier Wipes Stomahesive Strips SUR-FIT Plus Stomahesive Wafer with Flexible Collar Stomahesive Powder AutoLock SUR-FIT Durahesive FLEXIBLE Wafer Stomahesive Seal NATURA SUR-FIT Durahesive Flexible Wafer with Flexible Collar SUR-FIT Plus Durahesive with Convex-It Wafer LITTLE ONES Two-Piece Adhesive Stomahesive SENSI-CARE Barrier Spray Stomahesive Wafer NATURA Stomahesive Moldable Accordion Flange SUR-FIT NATURA Moldable Stomahesive with Hydrocolloid Flexible Collar Esenta Stomahesive Paste Esenta Stomahesive Seal SUR-FIT NATURA Urostomy Pouch with Accuseal Tap NATURA+ Urostomy Pouch SUR-FIT System Night Drainage Container ACTIVE LIFE CONVEX One-Piece Urostomy Pouch Durahesive SUR-FIT NATURA Urostomy Pouch ESTEEM SYNERGY Urostomy Pouch with Accuseal Tap ACTIVE LIFE One-Piece Urostomy Pouch Durahesive EsteemBody Urostomy Pouch Ostomy System ESTEEM Urostomy Pouch SUR-FIT Plus Urostomy Pouch Two-Piece Night Drainage Container Tubing Little Ones SUR-FIT NATURA Urostomy Pouch Two-Piece Ostomy System ESTEEM+ Urostomy Pouch Durahesive ESTEEM+ Soft CONVEX LITTLE ONES One-Piece Urostomy Pouch LITTLE ONES SUR-FIT Plus Two-Piece Close End Pouch ESTEEM Synergy+ Closed Pouch NATURA SUR-FIT Closed-End Pouch with Filter STOMADRESS Plus ACTIVE LIFE One-Piece Closed-End Pouch LITTLE ONES Two-Piece Adhesive Coupling Technology NATURA SUR-FIT Closed-End Mini Pouch NATURA SUR-FIT Closed-End Pouch SUR-FIT Plus Closed-End Pouch Two-Piece EsteemBody Closed Pouch Ostomy System SUR-FIT Plus Closed-End Pouch with Filter ESTEEM+ Soft CONVEX NATURA+ Closed Pouch ESTEEM+ Closed Pouch GentleCath Glide SUR-FIT NATURA Durahesive Skin Barrier/Pouch Unit Dose Kits ESTEEM Synergy Professional Kit - Non-Sterile EsteemBody Drainable Pouch Ostomy System Eakin Fistual and Wound Pouches ESENTA Strips Esteem + Drainable Pouch Trio Diamonds GentleTouch System OR Kit - Colostomy ESTEEM+ One-Piece Pouch Stomahesive Skin Barrier Kit Natura + Drainable Pouch SUR-FIT NATURA Stomahesive Skin Barrier/Pouch Unit Dose Kits ESTEEM Synergy Professional Kit - Loop Ostomy System - Sterile NATURA Stomahesive Skin Barrier Drainable Pouch Post Operative Kit with Loop Ostomy Rod NATURA Post-Operative Kits GentleTouch System OR Kit - Ileostomy and Urostomy NATURA Drainable and Urostomy Post-Operative Kits NATURA Stomahesive CTF Skin Barrier and Urostomy Kit Ostomy Appliance Belt Niko-Fix DUOACTIVE CGF Foam Lite ConvaTec GranuFlex Signal DuoDERM CGF Border DuoDERM E Border VariHesive Signal GranuFlex Extra Thin VARIHESIVE Extra Thin DuoDERM VISIDERM DuoDerm Border DuoDERM CGF DuoDERM Extra Thin DUOACTIVE Extra Thin VariHesive Extra Thin DUOACTIVE DuoDERM Signal CGF VariHesive CGF Border DuoDERM Extra Thin CGF DuoDERM Signal GranuFlex Border DuoDERM E ConvaTec™ Hydrocolloid Sealing Strips GranuFlex ESTEEM+ Soft CONVEX ActiveLife CONVEX One-Piece Drainable Pouch with Durahesive NATURA SUR-FIT High Output Drainable Pouch SUR-FIT Plus Drainable Pouch Two-Pieces SUR-FIT NATURA Drainable Pouch STOMADRESS Plus ActiveLife One-Piece Drainable Pouch with Stomahesive SUR-FIT NATURA Stomahesive NATURA SUR-FIT Drainable Pouch with InvisiClose Outlet COMBIHESIVE 2S LITTLE ONES One-Piece Drainable Pouch AutoLock SUR-FIT Drainable Pouch LITTLE ONES Two-Pieces Adhesive Coupling Technology ESTEEM SYNERGY Drainable Pouch SUR-FIT NATURA Drainable Pouch with Filter ActiveLife One-Piece Drainable Pouch with Durahesive NATURA+ Drainable Pouch LITTLE ONES Two-Pieces Drainable Pouch ESTEEM Synergy+ Drainable Pouch ESTEEM+ Drainable Pouch ActiveLife One-Piece Drainable Pouch with Durahesive Plus Flexi-Seal FMS Collection Bags Flexi-Seal SIGNAL Fecal Management System Cure Ultra ESTEEM synergy Professional Kit - Loop Ostomy System NATURA Stomahesive Post Operative Surgical Ostomy System SUR-FIT Loop Ostomy Rod GentleTouch Loop Ostomy Systems - Post Operative Kits Loop Ostomy Kits Loop Ostomy Rod ESTEEM SYNERGY Professional Kit NATURA Stomahesive Skin Barrier Drainable Pouch Post Operative Kit with Loop Ostomy Rod ConvaTec Loop Ostomy Rod AQUACEL Ag with Strengthening Fiber AQUACEL Ag Cure Closed System Cure Dextra Flexi-Seal SIGNAL Fecal Management System with Odor Barrier Flexi-Seal FMS Collection Bags Visi-Flow Irrigation Sleeve DIAMONDS Gelling and Odour Control Sachets ESENTA Lubricating Deodorant Loop Ostomy Rod CombiDERM Non-Adhesive Sterile Dressing AQUACEL Surgical ConvaFoam Silicone ConvaFoam Border CombiDERM ACD Sterile Dressing KALTOSTAT Alginate ConvaMax SUPERABSORBER Versiva AQUACEL Burn Aquacel ConvaFiber CarboFlex Versiva XC Adhesive Versiva XC Non-adhesive ConvaFoam Non-Adhesive AQUACEL Hydrofiber AQUACEL Foam AQUACEL Extra AQUACEL Extra Hydrofiber Dressing AQUACEL Foam Pro Flexi-Seal FMS Collection Bags Flexi-Seal PROTECT FMS with Luer Connector Flexi-Seal PROTECT FMS with EnFit Connector Drain-Fix Epi-FIx Stay-Fix

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic General, Plastic Surgery Class 1 878.4022 2006-01-27
EXE Protector, Ostomy Gastroenterology, Urology Class 1 876.5900 2005-06-06
EXG Bag, Urine Collecting, Ureterostomy Gastroenterology, Urology Class 1 876.5900 2016-12-09
EZQ Pouch, Colostomy Gastroenterology, Urology Class 1 876.5900 2005-06-06
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2016-09-27
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2016-09-27
FON Bag, Drainage, With Adhesive, Ostomy Gastroenterology, Urology Class 1 876.5900 2005-06-06
EZR Cement, Stomal Appliance, Ostomy Gastroenterology, Urology Class 1 876.5900 1981-06-01
KMK Device, Intravascular Catheter Securement General Hospital Class 1 880.5210 2009-04-28
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2007-05-17
EXH Bag, Urinary, Ileostomy Gastroenterology, Urology Class 1 876.5900 2007-05-17
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2012-05-10
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2024-03-21
EXB Collector, Ostomy Gastroenterology, Urology Class 1 876.5900 1996-11-19
EZP Rod, Colostomy Gastroenterology, Urology Class 2 876.4270 1996-11-19
FRO Dressing, Wound, Drug Unknown Class U N/A 2010-12-28
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2024-03-21
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2016-06-24
EXB Collector, Ostomy Gastroenterology, Urology Class 1 876.5900 1992-11-17
EZP Rod, Colostomy Gastroenterology, Urology Class 2 876.4270 2016-12-19
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2007-05-17
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2019-11-14
PIF Gastrointestinal Tubes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2019-11-14
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 1993-11-17

Official Correspondent

Jared Ragone

US Agent Details

Courtney Smith Business: ConvaTec Email: courtney.smith@convatec.com Phone: (603) 2470255

Related Public Records

Same Entity

ConvaTec
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3005778470 UNOMEDICAL S.R.O. MICHALOVCE Kosicky, SK
3012881740 ConvaTec Canada Ltd. Dorval Quebec, CA
3008806809 ConvaTec Limited, GDC Building Deeside Flintshire, GB
9618003 CONVATEC DOMINICAN REPUBLIC, INC. Haina San Cristobal, DO
3011987967 ConvaTec, Inc. Greensboro, NC, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K033719 C.R. Bard, Inc. BARD TIGERTAIL URETERAL CATHETER 2004-02-04
K820239 American Endoscopy, Inc. RETRIEVAL FORCEPS 1982-03-26
K041243 Tyco Healthcare DOVER RED RUBBER ROBINSON CATHETER 2004-07-07
K881936 Iberhospitex, S.A. OPER-FILM-ADHESIVE MEMBRANE 1988-08-31
K900590 Biosearch Medical Products, Inc. BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING 1990-08-02

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0010-2013 C.R. Bard, Inc., Urological Division 2
8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.
Z-0013-2019 COVIDIEN LLC 1
Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019 COVIDIEN LLC 1
Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019 COVIDIEN LLC 1
Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019 COVIDIEN LLC 1
Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000317571. Last updated year: 2026. Please use registration number 1000317571 when referencing this establishment in official correspondence.
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