BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    OPTIMUM MEDICAL

    Reg #: 3009086335 · FEI: 3009086335 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    16
    Establishment Types
    3
    Classifications
    8

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    Registration Details

    Registration Name
    OPTIMUM MEDICAL
    Registration Number
    3009086335
    FEI Number
    3009086335
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Tennant Hall, Bleinheim Grove
    City
    West Yorkshire Leeds
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K112110

    Owner / Operator

    Firm Name
    Optimum Medical
    Operator Number
    10041088
    Address
    Tennant Hall, Bleinheim Grove
    City
    West Yorkshire
    State
    Leeds
    Postal Code
    LS2 9ET
    Country
    GB

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Catheter, Retention Type, Balloon EZL
    Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile NNY
    Cup, Menstrual HHE
    System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile NNZ
    System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile EYZ
    Urinary Drainage Collection Kit, For Indwelling Catheter FCN
    Urinary Drainage Collection Kit PPG
    Lubricant, Patient KMJ

    Proprietary Names

    OptiPure Sheath (Male External Catheters) Ovio Cup Ugo Fix Gentle catheter clip Ugo Hanger (Drainage Bag Holder) Ugo Drainage Leg Bags Ugo 2L Drainage Bags Ugo Fix Bag Belt Multi Fix Gentle Ugo Fix Sleeve Ugo Stand with Dignity Ugo Fix Catheter Strap Ugo Catheter Valve Nexus Ugo 4 Weeks OptiLube

    Establishment Types

    Foreign Private Label Distributor Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device