BEUDAMED
    FDA Registration Inactive 🇺🇸 United States

    LERAISE HEALTH INTERNATIONAL LLC

    · Expires 2026
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

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    Registration Details

    Registration Name
    LERAISE HEALTH INTERNATIONAL LLC
    Status
    Inactive
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    8 The Grn Ste 1
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233146

    Owner / Operator

    Firm Name
    Leraise Health International LLC
    Operator Number
    10095962
    Address
    8 The Grn Ste 1
    City
    Dover
    State
    DE
    Postal Code
    19901
    Country
    US
    Correspondent
    Rae Fan

    Products

    Device Name Product Code
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    System, Test, Blood Glucose, Over The Counter NBW

    Proprietary Names

    Electronic Blood Pressure Monitor; model: B13A Electronic Blood Pressure Monitor; model: TMB-1117-SN Blood Glucose Monitoring System, Blood Glucose Meter and Test Strips Kit; model: 513S

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198