BEUDAMED
    FDA Registration Active 🇨🇳 China

    Dental Unit

    Reg #: 3013237609 · FEI: 3013237609 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    FOSHAN GLADENT MEDICAL INSTRUMENT CO.,LTD.
    Registration Number
    3013237609
    FEI Number
    3013237609
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 2 Plant No.1, 1st Rd., Lianhe Fenggang Industrial Zone, Lianhe Luocun Nanhai
    City
    Foshan Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K063302

    Owner / Operator

    Firm Name
    Foshan Gladent Medical Instrument Co.,Ltd.
    Operator Number
    10055871
    Address
    No. 2 Plant No.1,1st Rd., Lianhe Fenggang Industrial Zone, Luocun, Shishan Town, Nanhai
    City
    Foshan
    State
    Guangdong
    Postal Code
    528000
    Country
    CN

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Reserach Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Unit, Operative Dental EIA

    Proprietary Names

    Dental Unit

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device