BEUDAMED
    FDA Registration Active 🇮🇳 India

    Frontier X Plus

    Reg #: 3023146633 · FEI: 3023146633 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    KAYNES TECHNOLOGY INDIA LIMITED
    Registration Number
    3023146633
    FEI Number
    3023146633
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    23-25,Belagola Food Ind Area, Metagalli PO
    City
    Mysore Karnataka
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K240794

    Owner / Operator

    Firm Name
    Kaynes Technology India Limited
    Operator Number
    10089576
    Address
    23-25, Belagola Food Ind Area, Metagalli PO
    City
    Mysore
    State
    Karnataka
    Postal Code
    570016
    Country
    IN

    US Agent

    Business Name
    QA/RA Consulting Group, Inc.
    Contact Name
    Scott Bednar
    Address
    3335 Tuscarawas Rd
    City
    Beaver
    State
    PA
    ZIP
    15009
    Country
    US
    Email
    [email protected]
    Phone
    412 4188066

    Products

    Device Name Product Code
    Electrocardiograph DPS
    Electrocardiograph, Ambulatory, With Analysis Algorithm MLO
    Transmitters And Receivers, Electrocardiograph, Telephone DXH

    Proprietary Names

    Frontier X Plus

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)