BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    #K000340

    Reg #: 9610632 · FEI: 3002808026 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ROCKET MEDICAL PLC
    Registration Number
    9610632
    FEI Number
    3002808026
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Sedling Road
    City
    WASHINGTON Sunderland
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K000340

    Owner / Operator

    Firm Name
    Rocket Medical Plc
    Operator Number
    8010022
    Address
    Imperial Way, --
    City
    Watford
    State
    Hertfordshire
    Postal Code
    WD2 4XX
    Country
    GB

    US Agent

    Business Name
    Rocket Medical LLC
    Contact Name
    Thomas Dutheil
    Address
    50 Corporate Park Drive, Unit 890
    City
    East Pembroke
    State
    MA
    ZIP
    02359
    Country
    US
    Email
    [email protected]
    Phone
    781 7496223

    Products

    Device Name Product Code
    Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) HES

    Proprietary Names

    #K000340 R57424 HSG & HyCoSy Catheter 7Fg R57422-00-PK HSG Procedure Pack 5Fg R57422-ST-PK HSG Procedure Pack - 5Fg with Stylet R57422 HSG & HyCoSy Catheter 5Fg R57424-00-PK HSG Procedure Pack 7Fg R57422-00-ST HSG & HyCoSy Catheter with Stylet 5Fg R57424-ST-PK HSG Procedure Pack - 7Fg with Stylet R57424-00-ST HSG & HyCoSy Catheter with Stylet 7Fg R57430-CONE Hysterocone - 6Fg HSG & HyCoSy Catheter

    Establishment Types

    Manufacture Medical Device