BEUDAMED
    FDA Registration Active 🇨🇳 China

    HDR-461

    Reg #: 3013039893 · FEI: 3013039893 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SHANGHAI HANDY MEDICAL EQUIPMENT CO., LTD.
    Registration Number
    3013039893
    FEI Number
    3013039893
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Bldg No.11, Lane 177, Fulian Er Road, Baoshan District
    City
    Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K221008

    Owner / Operator

    Firm Name
    Shanghai Handy Medical Equipment Co., Ltd.
    Operator Number
    10054306
    Address
    Bldg No.11, Lane 177, Fulian Er Road, Baoshan District
    City
    Shanghai
    State
    CN-SH
    Postal Code
    201906
    Country
    CN
    Correspondent
    Marcia Qiu

    US Agent

    Business Name
    510K FDA Inc.
    Contact Name
    Claude Berthoin
    Address
    156 E GRANADA BLVD
    City
    Ormond Beach
    State
    FL
    ZIP
    32176
    Country
    US
    Email
    [email protected]
    Phone
    386 8710908

    Products

    Device Name Product Code
    System, X-Ray, Extraoral Source, Digital MUH

    Proprietary Names

    HDR-461 HDR-361 HDR Sensor

    Establishment Types

    Manufacture Medical Device