BEUDAMED
    FDA Registration Active 🇸🇰 Slovakia

    UNOMEDICAL S.R.O.

    Reg #: 3005778470 · FEI: 3005778470 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    42
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    UNOMEDICAL S.R.O.
    Registration Number
    3005778470
    FEI Number
    3005778470
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    PRIEMYSELNY PARK 3
    City
    MICHALOVCE Kosicky
    Country
    SK

    Regulatory Submissions

    510(k) Number
    K232665

    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
    State
    MA
    ZIP
    02420
    Country
    US
    Email
    [email protected]
    Phone
    603 2470255

    Products

    Device Name Product Code
    Pouch, Colostomy EZQ
    Catheter, Urological KOD
    Catheter, Straight EZD
    Catheter, Urethral GBM
    Bag, Urinary, Ileostomy EXH

    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 GentleCath Intermittent Urinary Catheter GentleCath Air for Women GentleCath Glide GentleCath Air for Men 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 GentleCath Glide Intermittent Urinary Catheter (Tiemann) GentleCath Glide Intermittent Urinary Catheter (female) GentleCath Glide Intermittent Urinary Catheter (male) Drainage Catheter Urological Catheter

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)