BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    DIGITIMER LTD.

    Reg #: 3003631667 · FEI: 3003631667 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    5
    Establishment Types
    3
    Classifications
    5

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    Registration Details

    Registration Name
    DIGITIMER LTD.
    Registration Number
    3003631667
    FEI Number
    3003631667
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    37 HYDEWAY
    City
    Welwyn Garden City Hertfordshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K172381

    Owner / Operator

    Firm Name
    DIGITIMER LTD.
    Operator Number
    9043315
    Address
    37 HYDEWAY, WELWYN GARDEN CITY
    City
    HERTFORDSHIRE
    State
    GB-NOTA
    Postal Code
    AL7 3BE
    Country
    GB

    US Agent

    Business Name
    Digitimer North America, LLC
    Contact Name
    Steven Valenti
    Address
    1 E Broward Blvd Ste 700
    City
    Fort Lauderdale
    State
    FL
    ZIP
    33301
    Country
    US
    Email
    [email protected]
    Phone
    954 3341070

    Products

    Device Name Product Code
    Stimulator, Muscle, Powered IPF
    Connector, Ureteral Catheter EYK
    Stimulator, Electrical, Evoked Response GWF
    Cystometer, Electrical Recording EXQ
    Transducer, Miniature Pressure IKE

    Proprietary Names

    Digitimer DS7AP Constant Current Stimulator Digitimer Urodynamics Catheters & Accessories D185 MultiPulse Cortical Stimulator DS7AH Constant Current Stimulator Cuillin Nanolgger

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device