BEUDAMED
    FDA Registration Active 🇮🇩 Indonesia

    UNIVERSAL GLOVES

    Reg #: 3007471500 · FEI: 3007471500 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    PT. UNIVERSAL GLOVES
    Registration Number
    3007471500
    FEI Number
    3007471500
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    JL. PERTAHANAN NO.17 PATUMBAK, DELI SERDANG
    City
    MEDAN Sumatera Utara
    Country
    ID

    Regulatory Submissions

    510(k) Number
    K203074

    Owner / Operator

    Firm Name
    PT. UNIVERSAL GLOVES
    Operator Number
    10061303
    Address
    JL. PERTAHANAN NO.17 PATUMBAK, DELI SERDANG
    City
    MEDAN
    State
    Sumatera Utara
    Postal Code
    20361
    Country
    ID
    Correspondent
    SUTOPO SUTOPO

    US Agent

    Business Name
    AMMEX CORPORATION
    Contact Name
    SASITHARAN NAIR
    Address
    1019 W JAMES ST #200
    City
    Kent
    State
    WA
    ZIP
    98032
    Country
    US
    Email
    [email protected]
    Phone
    425 2514000

    Products

    Device Name Product Code
    Latex Patient Examination Glove LYY
    Polymer Patient Examination Glove LZA

    Proprietary Names

    UNIVERSAL GLOVES

    Establishment Types

    Manufacture Medical Device