BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AB-6100

    Reg #: 1226587 · FEI: 3003046678 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    HAI LABORATORIES, INC.
    Registration Number
    1226587
    FEI Number
    3003046678
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    320 Massachusetts Ave
    City
    LEXINGTON
    State
    MA
    ZIP
    02420
    Country
    US

    Regulatory Submissions

    510(k) Number
    K063433

    Owner / Operator

    Firm Name
    HAI LABORATORIES, INC.
    Operator Number
    9040002
    Address
    320 MASSACHUSETTS AVE., --
    City
    Lexington
    State
    MA
    Postal Code
    02420
    Country
    US
    Correspondent
    VIVIAN - XUE

    Products

    Device Name Product Code
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    AB-6100 AB-6200

    Establishment Types

    Repack or Relabel Medical Device