BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CareTouch USA

    Reg #: 3016774562 · FEI: 3016774562 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Whele LLC
    Registration Number
    3016774562
    FEI Number
    3016774562
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    801 Barton Springs Rd
    City
    Austin
    State
    TX
    ZIP
    78704
    Country
    US

    Regulatory Submissions

    510(k) Number
    K220475

    Owner / Operator

    Firm Name
    Whele, LLC
    Operator Number
    10079252
    Address
    501 Boylston St, 09B133
    City
    Boston
    State
    MA
    Postal Code
    02116
    Country
    US

    Products

    Device Name Product Code
    Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK
    Multiple Use Blood Lancet For Single Patient Use Only QRL

    Proprietary Names

    CareTouch USA

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198