BEUDAMED
    FDA Registration Active 🇮🇩 Indonesia

    TelePatch Cardiac Monitor

    Reg #: 3006948155 · FEI: 3009865005 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    PT Giken Precision Indonesia
    Registration Number
    3006948155
    FEI Number
    3009865005
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    JL. Yos Sudarso Citra Buana Industrial Park II Lot 2 Batu Ampar Batam
    City
    Batam Riau
    Country
    ID

    Regulatory Submissions

    510(k) Number
    K161916

    Owner / Operator

    Firm Name
    Giken Sakata (S) Ltd
    Operator Number
    10087342
    Address
    Blk 4012 Ang Mo Kio Ave 10, #05-01 Techplace 1
    City
    Singapore
    State
    Central Singapore
    Postal Code
    569628
    Country
    SG
    Correspondent
    James Poo

    US Agent

    Business Name
    Medicomp Inc
    Contact Name
    Carla Snyder
    Address
    600 Atlantis Rd
    City
    Melbourne
    State
    FL
    ZIP
    32904
    Country
    US
    Email
    [email protected]
    Phone
    678 2328188

    Products

    Device Name Product Code
    Electrocardiograph, Ambulatory, With Analysis Algorithm MLO
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG

    Proprietary Names

    TelePatch Cardiac Monitor

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)