BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    MONITEX INDUSTRIAL CO., LTD.

    Reg #: 3003169405 · FEI: 3003169405 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    7

    Registration Details

    Registration Name
    MONITEX INDUSTRIAL CO., LTD.
    Registration Number
    3003169405
    FEI Number
    3003169405
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6F, 70 GUANG-FU RD., SEC 1,
    City
    SAN-CHUNG CITY Taipei
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K152192

    Owner / Operator

    Firm Name
    MONITEX INDUSTRIAL CO., LTD.
    Operator Number
    9044777
    Address
    6F, 70 GUANG-FU RD., SEC 1,, SAN-CHUNG DIST.
    City
    NEW TAIPEI CITY
    State
    TW-NOTA
    Postal Code
    241-58
    Country
    TW

    Products

    Device Name Product Code
    Syringe, Restorative And Impression Material EID
    Material, Impression Tray, Resin EBH
    Activator, Ultraviolet, For Polymerization EBZ
    Heat Source For Bleaching Teeth EEG
    Mixer, Cement, For Clinical Use JDZ
    Amalgamator, Dental, Ac-Powered EFD
    Syringe, Irrigating (Non Dental) KYZ

    Proprietary Names

    Kerr Henry Schein Maxima Advanced 3000 LED Curing Light WE Light Class II Darby Monitex Industrial Co., Ltd GX-330 ACE

    Establishment Types

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