BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    AL-SENSE

    Reg #: 3004869443 · FEI: 3004869443 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PEPTONIC MEDICAL ISRAEL, LTD.
    Registration Number
    3004869443
    FEI Number
    3004869443
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    HAESHEL ST. 7
    City
    CAESAREA Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K071100

    Owner / Operator

    Firm Name
    Peptonic Medical Israel Ltd
    Operator Number
    10083735
    Address
    7 Haeshel st
    City
    Caesarea
    State
    IL-NOTA
    Postal Code
    3088900
    Country
    IL
    Correspondent
    Hadar Kessary Shoham

    US Agent

    Business Name
    Common Sense Marketing Inc
    Contact Name
    Mikael Svensson
    Address
    4472 Saint Andrews Blvd.
    City
    Irving
    State
    TX
    ZIP
    75038
    Country
    US
    Email
    [email protected]
    Phone
    310 4987448

    Products

    Device Name Product Code
    Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN

    Proprietary Names

    AL-SENSE AmniScreen(TM)

    Establishment Types

    Manufacture Medical Device