BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Zio® XT Patch

    Reg #: 3016601273 · FEI: 3016601273 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    iRhythm Technologies, Ltd.
    Registration Number
    3016601273
    FEI Number
    3016601273
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Seal House, 56 London Road
    City
    Bagshot Surrey
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K121319

    Owner / Operator

    Firm Name
    iRhythm Technologies, Inc.
    Operator Number
    10026250
    Address
    699 8th St, Suite 600
    City
    San Francisco
    State
    CA
    Postal Code
    94103
    Country
    US
    Correspondent
    Chanda Owens

    US Agent

    Business Name
    IRHYTHM TECHNOLOGIES, INC.
    Contact Name
    Chanda Owens
    Address
    699 8th St, Suite 600
    City
    San Francisco
    State
    CA
    ZIP
    94103
    Country
    US
    Email
    [email protected]
    Phone
    408 5182578

    Products

    Device Name Product Code
    Recorder, Magnetic Tape, Medical DSH

    Proprietary Names

    Zio® XT Patch Zio® XT Patch CE

    Establishment Types

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