BEUDAMED
    FDA Registration Active 🇨🇳 China

    Safety Blood Collection Device for Single Use

    Reg #: 3009746425 · FEI: 3009746425 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Gemtier Medical (Shanghai) Inc.
    Registration Number
    3009746425
    FEI Number
    3009746425
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 18, Jianding Road, Fengjing Town,, Jinshan District
    City
    Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K170276

    Owner / Operator

    Firm Name
    Gemtier Medical (Shanghai) Inc.
    Operator Number
    10041480
    Address
    No. 18, Jianding Road, Fengjing Town,, Jinshan District
    City
    Shanghai
    State
    CN-SH
    Postal Code
    201502
    Country
    CN

    US Agent

    Business Name
    MYCO Medical Supplies, Inc.
    Contact Name
    Sanjiv Kumar
    Address
    2015 Production Drive
    City
    Apex
    State
    NC
    ZIP
    27539
    Country
    US
    Email
    [email protected]
    Phone
    919 4602535 ext. 105

    Products

    Device Name Product Code
    Needle, Hypodermic, Single Lumen FMI
    Set, Administration, Intravascular FPA

    Proprietary Names

    Safety Blood Collection Device for Single Use RELI

    Establishment Types

    Manufacture Medical Device