BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Swan

    Reg #: 9616787 · FEI: 3006654321 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    5
    Classifications
    1

    Registration Details

    Registration Name
    MEDISIM LTD.
    Registration Number
    9616787
    FEI Number
    3006654321
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5 Professor Avraham Patchornik Street, 6th Floor, Building A
    City
    Ness Ziona Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K051422

    Owner / Operator

    Firm Name
    MEDISIM LTD.
    Operator Number
    9035477
    Address
    6th Floor, Building A, 5 Professor Avraham Patchornik Street
    City
    Ness Ziona
    State
    IL-NOTA
    Postal Code
    7413014
    Country
    IL
    Correspondent
    Ilan - Vadai

    US Agent

    Business Name
    President Medisim USA Inc.
    Contact Name
    John Wilson
    Address
    505 Chrismill Lane Holly Springs, NC 27540 USA
    City
    Holly Springs
    State
    NC
    ZIP
    27540
    Country
    US
    Email
    [email protected]
    Phone
    847 6822791

    Products

    Device Name Product Code
    Continuous Measurement Thermometer FLL

    Proprietary Names

    Swan FHT5 FHT2 - Temple Touch Premium

    Establishment Types

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