BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    ME-APDS™

    Reg #: 3030626336 · FEI: 3030626336 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    MAGENTIQ EYE LTD
    Registration Number
    3030626336
    FEI Number
    3030626336
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6 Ben-Gurion Blvd.
    City
    Haifa
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K223473

    Owner / Operator

    Firm Name
    Magentiq Eye Ltd
    Operator Number
    10090333
    Address
    6 Ben-Gurion Blvd.
    City
    Haifa
    State
    IL-HA
    Postal Code
    3541416
    Country
    IL
    Correspondent
    Dror Zur

    US Agent

    Business Name
    Medical Device Post-Production Services, Inc.
    Contact Name
    Robert J Duffy
    Address
    16405 Summer Sage Rd
    City
    Poway
    State
    CA
    ZIP
    92064
    Country
    US
    Email
    [email protected]
    Phone
    858 4871859

    Products

    Device Name Product Code
    Gastrointesinal Lesion Software Detection System QNP

    Proprietary Names

    ME-APDS™ MAGENTIQ-COLO™

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device