BEUDAMED
    FDA Registration Active 🇨🇳 China

    OB-Tools Ltd.

    Reg #: 3007048259 · FEI: 3007048259 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    CHINA QINGDAO BRIGHT MEDICAL MANUFACTURING CO.,LTD.
    Registration Number
    3007048259
    FEI Number
    3007048259
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.1 Tiankang Road, Chengyang District
    City
    Qingdao Shandong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K150398

    Owner / Operator

    Firm Name
    China Qingdao Bright Medical Manufacturing CO.,Ltd.
    Operator Number
    10025835
    Address
    No.1, Tiankang Road, Chengyang District
    City
    Qingdao
    State
    Shandong
    Postal Code
    266107
    Country
    CN

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    System, Monitoring, Perinatal HGM
    Uterine Electromyographic Monitor OSP

    Proprietary Names

    OB-Tools Ltd.

    Establishment Types

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