BEUDAMED
    FDA Registration Active 🇨🇳 China

    AquaPak Humidifier Adapters; Aquapak Sterile Humidifier Reservoirs; AquaPak Bubble Prefilled Humidif

    Reg #: 9616874 · FEI: 3006403682 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    JIANERKANG MEDICAL CO., LTD.
    Registration Number
    9616874
    FEI Number
    3006403682
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.1, Jianerkang Road, Zhixi Town Industrial Zone Jintan District
    City
    Changzhou City Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K141353

    Owner / Operator

    Firm Name
    JIANERKANG MEDICAL CO., LTD.
    Operator Number
    9041776
    Address
    No.1 Jianerkang Road, Industrial Zone, Zhixi Town, Jintan District
    City
    Changzhou City
    State
    Jiangsu
    Postal Code
    213251
    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
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT

    Proprietary Names

    AquaPak Humidifier Adapters; Aquapak Sterile Humidifier Reservoirs; AquaPak Bubble Prefilled Humidif Aquapak Prefilled Humidifier

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)