BEUDAMED
    FDA Registration Active 🇮🇩 Indonesia

    DYONICS LAPAROSCOPY SYSTEM

    Reg #: 3007516837 · FEI: 3007516837 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    PT. TEAM-METAL INDONESIA
    Registration Number
    3007516837
    FEI Number
    3007516837
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    JL BRIGJEN KATAMSO NO7-8,KAWASAN BINTANG INDUSTRI II, TANJUNG UNCANG. P. BATAM
    City
    BATAM Kepulauan Riau
    Country
    ID

    Regulatory Submissions

    510(k) Number
    K914919

    Owner / Operator

    Firm Name
    TEAM-METAL(S) PRIVATE LIMITED
    Operator Number
    10028595
    Address
    31KAKI BUKIT VIEW
    City
    SINGAPORE
    State
    SG-NOTA
    Postal Code
    415964
    Country
    SG

    US Agent

    Business Name
    IRC USA
    Contact Name
    Charles Mack
    Address
    2950 E Lindrick Dr
    City
    Chandler
    State
    AZ
    ZIP
    85249
    Country
    US
    Email
    [email protected]
    Phone
    931 6254938

    Products

    Device Name Product Code
    Laparoscope, General & Plastic Surgery GCJ

    Proprietary Names

    DYONICS LAPAROSCOPY SYSTEM

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device