BEUDAMED
    FDA Registration Active 🇨🇳 China

    Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System (Control module and Holster)

    Reg #: 3006063136 · FEI: 3006063136 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Plexus (Xiamen) Co. Ltd.,
    Registration Number
    3006063136
    FEI Number
    3006063136
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No 6, Xiangxing 2 Road, Xiamen area of China (FUJIAN) pilot free trade zone
    City
    Xiamen, Fujian
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K202012

    Owner / Operator

    Firm Name
    PLEXUS CORP.
    Operator Number
    3019588
    Address
    ONE PLEXUS WAY, --
    City
    Neenah
    State
    WI
    Postal Code
    54956
    Country
    US

    Products

    Device Name Product Code
    Instrument, Biopsy KNW

    Proprietary Names

    Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System (Control module and Holster)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)