BEUDAMED
    FDA Registration Active 🇩🇴 Dominican Republic

    CONVATEC DOMINICAN REPUBLIC, INC.

    Reg #: 9618003 · FEI: 3003264198 · Expires 2026
    View on FDA
    Products
    16
    Proprietary Names
    194
    Establishment Types
    2
    Classifications
    16

    Registration Details

    Registration Name
    CONVATEC DOMINICAN REPUBLIC, INC.
    Registration Number
    9618003
    FEI Number
    3003264198
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    CARRETERA SANCHEZ, KM. 18.5, PARQUE INDUSTRIAL ITABO, S.A., Buildings 8A, 23, 29, 30
    City
    Haina San Cristobal
    Country
    DO

    Regulatory Submissions

    510(k) Number
    K811160

    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
    Pouch, Colostomy EZQ
    Irrigator, Ostomy EXD
    Dressing, Wound, Drug FRO
    Bag, Drainage, With Adhesive, Ostomy FON
    Tubes, Gastrointestinal (And Accessories) KNT
    Bag, Urinary, Ileostomy EXH
    Rod, Colostomy EZP
    Bag, Urine Collecting, Ureterostomy EXG
    Protector, Ostomy EXE
    Dressing, Wound, Hydrophilic NAC
    Appliance, Colostomy, Disposable EZS
    Collector, Ostomy EXB
    Gastrointestinal Tubes With Enteral Specific Connectors PIF
    Ostomy Care Kit PQE
    Dressing, Wound, Occlusive NAD
    Cement, Stomal Appliance, Ostomy EZR

    Proprietary Names

    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 Visi-Flow Irrigation Sleeve SUR-FIT Irrigation Sleeve Visi-Flow Irrigation Sleeve Tail Closure AQUACEL Ag Surgical SP AQUACEL Ag Advantage Surgical SP Natura SUR-FIT Irrigation Visi-Flow Irrigator Visi-Flow Irrigation System Visi-Flow Stoma Cone Visi-Flow Irrigator Set 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 Flexi-Seal SIGNAL Fecal Management System with Odor Barrier Flexi-Seal FMS Collection Bags 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 Loop Ostomy Rod Flexi-Seal PROTECT Fecal Management System with ENFIT Flexi-Seal PROTECT Fecal Management System 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 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 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 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 SUR-FIT NATURA Flange Cap with Filter DIAMONDS Gelling and Odour Control Sachets ESENTA Lubricating Deodorant Flexi-Seal AIR (with ENFit Connector) Flexi Seal Air Bag 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 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 ConvaTec Loop Ostomy Rod Flexi-Seal PROTECT FMS with Luer Connector Flexi-Seal PROTECT FMS with EnFit Connector 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 Ostomy Appliance Belt AQUACEL Ag Advantage Surgical AQUACEL Ag Surgical

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device