BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Minuteful - kidney test

    Reg #: 3015921024 · FEI: 3015921024 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    HEALTHY.IO LTD.
    Registration Number
    3015921024
    FEI Number
    3015921024
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8 Yitzhak Sadeh St.
    City
    Tel Aviv
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K210069

    Owner / Operator

    Firm Name
    Healthy.io Ltd.
    Operator Number
    10062175
    Address
    8 Yitzhak Sadeh St.
    City
    Tel Aviv
    State
    IL-TA
    Postal Code
    6777508
    Country
    IL

    US Agent

    Business Name
    Healthy.io
    Contact Name
    Rebecca LaFond
    Address
    9288 LaFond Drive
    City
    Helena
    State
    MT
    ZIP
    59602
    Country
    US
    Email
    [email protected]
    Phone
    734 9452851

    Products

    Device Name Product Code
    Enzymatic Method, Creatinine JFY
    Automated Urinalysis System KQO
    Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR

    Proprietary Names

    Minuteful - kidney test

    Establishment Types

    Manufacture Medical Device