BEUDAMED
    FDA Registration Active 🇮🇩 Indonesia

    UNISEAL Powder Free Latex Examination Gloves Blue Colored

    Reg #: 8041092 · FEI: 3002914051 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    PT. INTAN HEVEA INDUSTRY
    Registration Number
    8041092
    FEI Number
    3002914051
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    JL.PULAU IRIAN (KAWASAN INDUSTRY MEDAN), JL. KOM LAUT YOS SUDARSO KM 10.5
    City
    MEDAN Sumatera Utara
    Country
    ID

    Regulatory Submissions

    510(k) Number
    K983614

    Owner / Operator

    Firm Name
    PT. INTAN HEVEA INDUSTRY
    Operator Number
    8041092
    Address
    JALAN PULAU IRIAN NO.13, KAWASAN INDUSTRI MEDAN 1, MABAR
    City
    MEDAN
    State
    Sumatera Utara
    Postal Code
    20371
    Country
    ID
    Correspondent
    MANSUR - TANDJO

    US Agent

    Business Name
    KEMCO SUPPLY
    Contact Name
    KENMAYNARD KENMAYNARD
    Address
    20733 S.E. 4TH
    City
    SAMMAMISH
    State
    WA
    ZIP
    98074
    Country
    US
    Email
    [email protected]
    Phone
    425 3924803

    Products

    Device Name Product Code
    Latex Patient Examination Glove LYY

    Proprietary Names

    UNISEAL Powder Free Latex Examination Gloves Blue Colored

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device