BEUDAMED
    FDA Registration Active 🇨🇳 China

    FOSHAN GLADENT MEDICAL INSTRUMENT CO.,LTD.

    Reg #: 3013237609 · FEI: 3013237609 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    6

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    Registration Details

    Registration Name
    FOSHAN GLADENT MEDICAL INSTRUMENT CO.,LTD.
    Registration Number
    3013237609
    FEI Number
    3013237609
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Room 201, 301, 401, Building 2, Wanyang Kexing Park,No.84, Taoyuan East Road, Shishan Town, Nanhai District
    City
    Foshan Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K071353

    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, Accessories NRD
    Chair, Dental, With Operative Unit KLC
    Unit, Operative Dental EIA
    Unit, Suction Operatory EBR
    Needle, Dental DZM
    Cabinet, Table And Tray, Anesthesia BRY

    Proprietary Names

    Dental Intraoral camera and Dental air compressor Dental Chair With Operative Unit Dental Unit NEEDLE, DENTAL-Dental Burs Dental cabinet, table and tray

    Establishment Types

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