BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    SeQure

    Reg #: 3011890588 · FEI: 3011890588 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ACCURATE MEDICAL THERAPEUTICS LTD.
    Registration Number
    3011890588
    FEI Number
    3011890588
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    19 Eli Hurvitz Street
    City
    Rehovot Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K203487

    Owner / Operator

    Firm Name
    Accurate Medical Therapeutics Ltd.
    Operator Number
    10057629
    Address
    19 Eli Hurvitz Street
    City
    Rehovot
    State
    IL-NOTA
    Postal Code
    7608802
    Country
    IL
    Correspondent
    Osnat Harbater

    US Agent

    Business Name
    Guerbet USA
    Contact Name
    Haewon Park
    Address
    214 Carnegie Ctr Suite 300
    City
    Princeton
    State
    NJ
    ZIP
    08540
    Country
    US
    Email
    [email protected]
    Phone
    609 4239641

    Products

    Device Name Product Code
    Catheter, Intravascular, Diagnostic DQO

    Proprietary Names

    SeQure Drakon

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility