BEUDAMED
    FDA Registration Active 🇨🇳 China

    extriCARE Large Foam Kit

    Reg #: 3004022422 · FEI: 3004022422 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SHANGHAI ISO MEDICAL PRODUCTS CO., LTD.
    Registration Number
    3004022422
    FEI Number
    3004022422
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    999 LIUCHEN ROAD, PUDONG NEW AREA
    City
    SHANGHAI
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K140634

    Owner / Operator

    Firm Name
    SHANGHAI ISO MEDICAL PRODUCTS CO., LTD.
    Operator Number
    9056122
    Address
    999LIUCHEN ROAD PUDONG NEW AREA
    City
    SHANGHAI
    State
    CN-SH
    Postal Code
    201202
    Country
    CN

    US Agent

    Business Name
    Hlongmed International Ltd.
    Contact Name
    Anny zhao
    Address
    1312 17th Street#692 Denver,CO 80202
    City
    Denver
    State
    CO
    ZIP
    80202
    Country
    US
    Email
    [email protected]
    Phone
    503 3344880

    Products

    Device Name Product Code
    Negative Pressure Wound Therapy Powered Suction Pump OMP

    Proprietary Names

    extriCARE Large Foam Kit extriCARE NPWT Drape - Two Adhesive Drape extriCARE NPWT Drape - One Adhesive Drape extriCARE Small Foam Kit extriCARE NPWT Drape extriCARE 3600 400cc Canister extriCARE2400 NPWT System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)