BEUDAMED
    FDA Registration Active 🇨🇳 China

    SHANGHAI MEKON MEDICAL DEVICES CO., LTD.

    Reg #: 3012552122 · FEI: 3012552122 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    11

    Registration Details

    Registration Name
    SHANGHAI MEKON MEDICAL DEVICES CO., LTD.
    Registration Number
    3012552122
    FEI Number
    3012552122
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    526, No. 697-3 Lingshi Road Shanghai China
    City
    shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K171518

    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
    Dispenser, Liquid Medication KYX
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
    System, Blood Collection, Vacuum-Assisted, Manual KST
    Needle, Hypodermic, Single Lumen FMI
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Ophthalmic Syringe QLY
    Low Dead Space Piston Syringe QNQ
    Syringe, Piston FMF
    Ophthalmic Needle QYM
    Low Dead Space Needle, Single Lumen, Hypodermic QNS
    Set, Administration, Intravascular FPA

    Proprietary Names

    oral syringe; oral dispensing syringe Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles Manual Vacuum-Assisted Blood Collection System OcuJect Ophthalmic Needle Needle OcuSafe® Ophthalmic Needle; VitreJect® Safety Ophthalmic Needle; SteriCap® Safety Ophthalmic Needle; Blood Collecting Needles VitreJect® Syringes;VitreJect® Ophthalmic Syringes MiniLoad® Syringes sterile insulin syringe for single use with needle(U-100) sterile insulin syringe for single use with needle(U-40) sterile hypodermic needle for single use Sterile hypodermic syringe for single use with/without needle OcuSafe® Needle;VitreJect® Safety Needle;Needle;LDS Needle OcuSafe® Ophthalmic Needle; VitreJect® Ophthalmic Safety Needle; SteriCap® Safety Needle; UltraFlo-R Push Button Blood Collection Set

    Establishment Types

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