BEUDAMED
    FDA Registration Active 🇨🇳 China

    Sterile hypodermic syringe for single use with/without needle

    Reg #: 3012552122 · FEI: 3012552122 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SHANGHAI MEKON MEDICAL DEVICES CO., LTD.
    Registration Number
    3012552122
    FEI Number
    3012552122
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    526, No. 697-3 Lingshi Road Shanghai China
    City
    shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K112057

    Owner / Operator

    Firm Name
    Shanghai Mekon Medical Devices Co., Ltd.
    Operator Number
    10059181
    Address
    526, No. 697-3 Lingshi Road Shanghai China
    City
    shanghai
    State
    CN-SH
    Postal Code
    200072
    Country
    CN
    Correspondent
    Xuanjin Qu

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.,
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Needle, Hypodermic, Single Lumen FMI
    Syringe, Piston FMF

    Proprietary Names

    Sterile hypodermic syringe for single use with/without needle sterile insulin syringe for single use with needle(U-40) sterile hypodermic needle for single use sterile insulin syringe for single use with needle(U-100)

    Establishment Types

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