BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Procept Biorobotics c/o HealthLink Europe B.V.

    Reg #: 3043534483 · FEI: 3043534483 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    Procept Biorobotics c/o HealthLink Europe B.V.
    Registration Number
    3043534483
    FEI Number
    3043534483
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Mechie Trommelenweg 8
    City
    Waalwijk Noord-Brabant
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K173000

    Owner / Operator

    Firm Name
    PROCEPT BioRobotics Corporation
    Operator Number
    10055490
    Address
    150 Baytech Drive
    City
    San Jose
    State
    CA
    Postal Code
    95134
    Country
    US
    Correspondent
    Ankur Kaushal

    US Agent

    Business Name
    PROCEPT BIOROBOTICS CORPORATION
    Contact Name
    Ankur Kaushal
    Address
    150 Baytech Dr
    City
    San Jose
    State
    CA
    ZIP
    95134
    Country
    US
    Email
    [email protected]
    Phone
    650 2327200

    Products

    Device Name Product Code
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX
    Drape, Urological, Disposable EYY
    Fluid Jet Removal System PZP

    Proprietary Names

    Apogee 2300 with transducers ECBP-1 Lithotomy Drape Aquablation Essential Drape Pack, DR2500 HYDROS Handpiece HYDROS TRUS Probe HYDROS Robotic System

    Establishment Types

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