BEUDAMED
    FDA Registration Active 🇨🇳 China

    AirNext Spirometer

    Reg #: 3007648426 · FEI: 3007648426 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Flexible Circuit Technologies Shenzhen
    Registration Number
    3007648426
    FEI Number
    3007648426
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    F3, Building 6,Lianlang Industrial Area, Dan Zhutou, Long Gang District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K183089

    Owner / Operator

    Firm Name
    Flexible Circuit Technologies
    Operator Number
    10029390
    Address
    9850 51st. Ave. N, Suite 110
    City
    Minneapolis
    State
    MN
    Postal Code
    55442
    Country
    US
    Correspondent
    Wendy Miller

    US Agent

    Business Name
    FLEXIBLE CIRCUIT TECHNOLOGIES
    Contact Name
    Danielle Clarke
    Address
    9850 51st Ave N Ste 110
    City
    Plymouth
    State
    MN
    ZIP
    55442
    Country
    US
    Email
    [email protected]
    Phone
    763 5453333

    Products

    Device Name Product Code
    Spirometer, Diagnostic BZG

    Proprietary Names

    AirNext Spirometer

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)