BEUDAMED
    FDA Registration Active 🇨🇳 China

    EGENS One Step HOG Urine Pregnancy Test Kit (Cassette)

    Reg #: 3008808082 · FEI: 3008808082 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    PLANET(SHANGHAI) INTERNATIONAL CO.,LTD
    Registration Number
    3008808082
    FEI Number
    3008808082
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    RM. 805-807, TONG DA MANSION, NO.1, LANE 600, TIANSHAN RD
    City
    shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K123050

    Owner / Operator

    Firm Name
    Planet(Shanghai) international Co.,Ltd
    Operator Number
    10034846
    Address
    RM. 805-807, TONG DA MANSION, NO.1, LANE 600, TIANSHAN RD
    City
    shanghai
    State
    CN-SH
    Postal Code
    200051
    Country
    CN

    Products

    Device Name Product Code
    Visual, Pregnancy Hcg, Prescription Use JHI
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX

    Proprietary Names

    EGENS One Step HOG Urine Pregnancy Test Kit (Cassette)

    Establishment Types

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