BEUDAMED
    FDA Registration Active 🇨🇳 China

    Clearblue Digital and Visual Pregnancy Kit

    Reg #: 3005128563 · FEI: 3005128563 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Abbott Diagnostics (Shanghai) Co., Ltd.
    Registration Number
    3005128563
    FEI Number
    3005128563
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    151 LIBING ROAD, China (Shanghai) Pilot Free Trade Zone
    City
    SHANGHAI
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K110433

    Owner / Operator

    Firm Name
    Abbott
    Operator Number
    9006731
    Address
    100 Abbott Park Road, Dept. RX51/J55/MS 6134
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    Products

    Device Name Product Code
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX

    Proprietary Names

    Clearblue Digital and Visual Pregnancy Kit Clearblue Pregnancy Planning Kit Clearblue Visual Preg Test

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)