BEUDAMED
    FDA Registration Active 🇨🇳 China

    DPS

    Reg #: 3008080537 · FEI: 3008080537 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    0

    Registration Details

    Registration Name
    HUAYI ISOTOPES CO.
    Registration Number
    3008080537
    FEI Number
    3008080537
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    18 Fuyu Road, Jiangsu Advanced Materials Industrial Park, Ha
    City
    Changshu city Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K875227

    Owner / Operator

    Firm Name
    HUAYI ISOTOPES CO.
    Operator Number
    10047992
    Address
    18 Fuyu Road, Jiangsu Advanced Materials
    City
    Changshu city
    State
    Jiangsu
    Postal Code
    215522
    Country
    CN

    US Agent

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

    Products

    Device Name Product Code
    LDH

    Proprietary Names

    DPS MD® Ophthalmic Dropper Bottles

    Establishment Types

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