BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Duet-3

    Reg #: 3003909093 · FEI: 3003909093 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BIOVIEW LTD.
    Registration Number
    3003909093
    FEI Number
    3003909093
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3 PAKRIS STREET
    City
    REHOVOT Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K130775

    Owner / Operator

    Firm Name
    BIOVIEW LTD.
    Operator Number
    9054795
    Address
    3 Pekeris Street, --
    City
    Rehovot
    State
    IL-NOTA
    Postal Code
    7670203
    Country
    IL
    Correspondent
    YUVAL - HARARI

    US Agent

    Business Name
    BIOVIEW USA INC.
    Contact Name
    David Kutas
    Address
    44 Manning Rd Ste 104
    City
    BILLERICA
    State
    MA
    ZIP
    01821
    Country
    US
    Email
    [email protected]
    Phone
    978 6704741

    Products

    Device Name Product Code
    System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays NTH
    Device, Automated Cell-Locating JOY

    Proprietary Names

    Duet-3 Solo™ Review workstation Encore Allegro Plus SoloWeb analysis configuration SIMP – (“Slide Interface Messaging Protocol”) Accord Plus Solo-Touch Review workstation

    Establishment Types

    Manufacture Medical Device