BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    ConvaTec Limited, GDC Building

    Reg #: 3008806809 · FEI: 3008806809 · Expires 2026
    View on FDA
    Products
    68
    Proprietary Names
    321
    Establishment Types
    1
    Classifications
    68

    Registration Details

    Registration Name
    ConvaTec Limited, GDC Building
    Registration Number
    3008806809
    FEI Number
    3008806809
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    First Avenue, Deeside Industrial Park
    City
    Deeside Flintshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K181206

    Owner / Operator

    Firm Name
    ConvaTec
    Operator Number
    2241599
    Address
    7815 National Service Road, Suite 600
    City
    Greensboro
    State
    NC
    Postal Code
    27409
    Country
    US
    Correspondent
    Jared Ragone

    US Agent

    Business Name
    ConvaTec
    Contact Name
    Courtney Smith
    Address
    20 Maguire
    City
    Lexington, MA
    State
    MA
    ZIP
    03841
    Country
    US
    Email
    [email protected]
    Phone
    603 2470255

    Products

    Device Name Product Code
    Catheter, Urethral GBM
    Connector, Catheter GCD
    Irrigator, Ostomy EXD
    Tubes, Gastrointestinal (And Accessories) KNT
    Gastrointestinal Tubes With Enteral Specific Connectors PIF
    Bandage, Elastic FQM
    Pouch, Colostomy EZQ
    Dressing, Wound, Occlusive NAD
    Dressing, Wound, Drug FRO
    Tape And Bandage, Adhesive KGX
    Catheter, Straight EZD
    Instrument, Surgical, Disposable KDC
    Clamp, Cannula FKC
    Nebulizer (Direct Patient Interface) CAF
    Device, Urine Flow Rate Measuring, Non-Electrical, Disposable FFG
    Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) FCM
    Device, Intravascular Catheter Securement KMK
    Set, Administration, Intravascular FPA
    Dressing, Wound, Hydrogel Without Drug And/Or Biologic NAE
    Drain, Tee (Water Trap) BYH
    Catheter And Tip, Suction JOL
    Bag, Urinary, Ileostomy EXH
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Filter, Bacterial, Breathing-Circuit CAH
    Negative Pressure Wound Therapy Powered Suction Pump OMP
    Bag, Urine Collecting, Ureterostomy EXG
    Device, Cystometric, Hydraulic FEN
    Catheter, Retention Type, Balloon EZL
    Mask, Oxygen, Low Concentration, Venturi BYF
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
    Catheter, Urological KOD
    Rod, Colostomy EZP
    Tube, Tracheal (W/Wo Connector) BTR
    Catheter, Nasal, Oxygen BZB
    Collector, Ostomy EXB
    Cannula, Nasal, Oxygen CAT
    Ostomy Care Kit PQE
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Bag, Reservoir BTC
    Mouthpiece, Breathing BYP
    Bag, Drainage, With Adhesive, Ostomy FON
    Appliance, Colostomy, Disposable EZS
    Tubing, Pressure And Accessories BYX
    Collector, Urine, (And Accessories) For Indwelling Catheter KNX
    Fiber, Medical, Absorbent FRL
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Catheter Care Tray OHR
    Cement, Stomal Appliance, Ostomy EZR
    Protector, Ostomy EXE
    Bandage, Liquid, Skin Protectant NEC
    Accessories, Catheter KGZ
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Mask, Gas, Anesthetic BSJ
    Connector, Airway (Extension) BZA
    Solvent, Adhesive Tape KOX
    Urinometer, Mechanical EXR
    Evacuator, Bladder, Manually Operated FFD
    Dressing, Wound, Hydrophilic NAC
    Tube Tracheostomy And Tube Cuff JOH
    Tube, Feeding FPD
    Mask, Oxygen BYG
    Stylet, Tracheal Tube BSR
    Condenser, Heat And Moisture (Artificial Nose) BYD
    Forceps HTD
    Ventilator, Emergency, Manual (Resuscitator) BTM
    Catheters, Suction, Tracheobronchial BSY
    System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile NNZ
    Mask, Oxygen, Non-Rebreathing KGB

    Proprietary Names

    GentleCath Glide Intermittent Urinary Catheter (Tiemann) GentleCath Glide Intermittent Urinary Catheter (female) GentleCath Glide Intermittent Urinary Catheter (male) Urological Catheter Smooth Bore Connector Drainage Catheter Spigot Catheter Plug Catheter Connector Visi-Flow Irrigator Visi-Flow Stoma Cone Visi-Flow Irrigation System Flexi-Seal AIR (with ENFit Connector) Flexi Seal Air Bag Unna-Flex SurePress High Compression Bandage Unna-Flex Unna Boot 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 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 Flexi-Seal SIGNAL Fecal Management System with Odor Barrier Flexi-Seal FMS Collection Bags Aquacel Ag Advantage Drain-Fix Epi-FIx Stay-Fix Cure Twist Disposable Surgical Instruments Tube Clamps Airways (Medication Nebulizer) UnoMeter Safeti Plus w/ Luer Sample Port Flexi-Seal SIGNAL Fecal Management System Cure Hydrophilic Catheter Kit (HM16UK) Cure Catheter Insertion Kit (K2-90) Cure Catheter Insertion Kit (K1) Cure Catheter Insertion Kit (K2) Cure Hydrophilic Catheter Kit (HM14UK) Cure Catheter Closed System Kit (CS10) Cure Catheter Closed System Kit (CS14C) Cure Catheter Closed System Kit (CS14) Cure Catheter Closed System Kit (CS8) Cure Pocket Catheter Kit (M14UK) Cure Hydrophilic Catheter Kit (HM12UK) Cure Catheter Closed System Kit (CS12) Cure Catheter Insertion Kit (K3) Niko-Fix GentleCath Air for Men Natura SUR-FIT Irrigation Visi-Flow Irrigator Set Asante Comfort Asante Conset DUODERM HYDROACTIVE GEL SAF-GEL Flexi-Seal PROTECT FMS with Luer Connector Flexi-Seal PROTECT FMS with EnFit Connector Airways Suction Tip Suction Catheters Catheter and Tip 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 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 Anesthesia Breathing Circuit Y-Connector Airways (Bacterial Filter) AVELLE Negative Pressure Wound Therapy System AVELLE Negative Pressure Wound Therapy Dressing 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 LITTLE ONES One-Piece Urostomy Pouch ABVISER Paediatric Hydrophilic Coated Foley Catheter Airways (Ventori Oxy Mask, Venturi Oxygen Mask) GentleCath™ Air for Men GentleCath™ Glide Intermittent Catheter GentleCath™ Air for Women HandyVac MiniVac UnoVac Siliconized Latex Foley Catheters Loop Ostomy Rod Airways (Reinforced Endotracheal Tube) Airways (Oxygen Catheter, Pharma-Plast Oxygen Catheter Urological Silicone Foley Catheter Drainage Silicone Foley Catheter 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 ESTEEM SYNERGY Professional Kit NATURA Stomahesive Skin Barrier Drainable Pouch Post Operative Kit with Loop Ostomy Rod ConvaTec Loop Ostomy Rod Airways (Mac-Safe Cannula, Oxygen Nasal Cannula) NATURA Drainable Invisiclose PO Kits NATURA Stomahesive Accuseal PO Kit ESTEEM SYNERGY ESTEEM+ Drainable PO Kits NATURA Durahesive ESTEEM+ Stomahesive NATURA Stomahesive NATURA Stomahesive PO Kit SUR-FIT NATURA Drainable Pouch Stomahesive Wafer with Flexible Collar GentleCath Air for Women Ventilator Circuit Ventilator Circuit IPPB Airways (Reservoir Bag, Bag, Reservoir) Cure Pediatric Catheter AQUACEL Ag Surgical SP AQUACEL Ag Advantage Surgical SP Airways (Mouthpiece) Cure Catheter Hydrophilic Coated 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 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 SUR-FIT NATURA Disposable Convex Insert Visi-FLow Irrigation Adapter Faceplate SUR-FIT Plus Straight Tail Closures DuoLock Curved Tail Closure ACTIVE LIFE One-Piece Stoma Cap with Skin Barrier Visi-Flow Irrigation Sleeve Tail Closure SUR-FIT NATURA Flange Cap with Filter AQUACEL Ag Foam GentleCath Intermittent Urinary Catheter Tubing Oxygen Connecting Tubes Accessories Oxygen Connecting Tubes Pressure and Accessories Urine Bags Flexi-Seal PROTECT Fecal Management System with ENFIT Flexi-Seal PROTECT Fecal Management System SurePress Absorbent Padding AQUACEL Ag EXTRA 365-E (ADULT) 367-E (PEDIATRIC) MAC-SAFE Cure Catheter Closed System Cure Catheter Tray Haematuria Foley Catheter Rubber Urethral Catheter GentleCath Glide AQUACEL Ag Advantage Surgical AQUACEL Ag Surgical Flexi-Seal Fecal Management System Ostomy Appliance Belt 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 SENSI-CARE Skin Barrier Foam Applicators ESENTA Sting Free Skin Barrier Wipes SENSI-CARE Skin Barrier Wipes Trio Silesse ESENTA Sting Free Skin Barrier Pump Spray SENSI-CARE Skin Barrier Spray ESENTA Sting Free Skin Barrier Spray ESENTA Sting Free Skin Barrier Foam Applicators Flexi-Trak Airways (Bubble Humidifier) Airways (Disposable Anesthesia Mask) Paediatric Endotracheal Tube Airways (Disposable 22 mm Adapter) Visi-Flow Irrigation Sleeve SUR-FIT Irrigation Sleeve SENSI-CARE Adhesive Remover Wipe SENSI-CARE Adhesive Releaser Spray ESENTA Adhesive Remover Wipes AllKare ESENTA Adhesive Remover Spray Unometer EasiVac 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 Hydrophilic Coated Foley Catheter Airways (Tracheostomy Tube) Silicone Coated Catheter AQUACEL Ag Burn Feeding Tube Airways (Oxygen Mask) Airways (Endotracheal Tube Airways (Warm-N-Wet HME) Forceps Airways (Disposable Manual Pulmonary Res.) Mucus extractors Mucus traps Suction Catheter Suction Catheter ProFlo AQUACEL Ag with Strengthening Fiber AQUACEL Ag Airways (Endotracheal Tube) Cure Catheter Extension Tube Cure Catheter Non-Rebreathing Oxygen Mask

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility