BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Biosense Webster (Israel), Ltd.

    Reg #: 3008203003 · FEI: 3008203003 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    19
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Biosense Webster (Israel), Ltd.
    Registration Number
    3008203003
    FEI Number
    3008203003
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4 Hatnufa Street
    City
    Yokneam Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K200484

    Owner / Operator

    Firm Name
    BIOSENSE WEBSTER, INC.
    Operator Number
    9044811
    Address
    31 Technology Drive, Suite 200, --
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Tucky Wong

    US Agent

    Business Name
    Biosense Webster Inc.
    Contact Name
    Tucky Wong
    Address
    31 Technology Dr. Suite 200
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 2413161

    Products

    Device Name Product Code
    Computer, Diagnostic, Programmable DQK
    Ear, Nose, And Throat Stereotaxic Instrument PGW

    Proprietary Names

    CARTO 3 EP Navigation System with Signal Processing Unit CARTO 3 EP Navigation System, Version 6 CARTO 3 System v6 with VISITAG SURPPOINT CARTO 3 System and Accessories, version 4.3.5 with Coherent Mapping CARTO 3 EP Navigation System Version 7.2 CARTO 3 EP NAVIGATION SYSTEM, V1 AND ACCESSORIES TruDi Navigation System V3 CARTO™ 3 EP Navigation System V8.1 CARTO ENT System TruDi Navigation System CARTO™ 3 EP Navigation System V9 with PIU Plus TruDi Navigation System, Rev 1.3 CARTO 3 System and Accessories v7 CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) CARTO 3 EP Navigation System & CARTO 3 External Reference Patches CARTO 3 system version 8 CARTO 3 EP Navigation System V8.4 Carto 3 System and Accessories, version 5 with CARTOFINDER CARTO 3 EP Navigation System with CARTOSOUND 4D v7/4

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)