BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    AKTIIA SA

    Reg #: 3019575688 · FEI: 3019575688 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    1

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    Registration Details

    Registration Name
    AKTIIA SA
    Registration Number
    3019575688
    FEI Number
    3019575688
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Rue du Bassin 8a,
    City
    Neuchatel
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K250415

    Owner / Operator

    Firm Name
    Aktiia SA
    Operator Number
    10092031
    Address
    Rue du Bassin 8a,
    City
    Neuchatel
    State
    CH-NE
    Postal Code
    2000
    Country
    CH
    Correspondent
    NEIL PURI

    US Agent

    Business Name
    Neil Puri
    Contact Name
    Neil Puri
    Address
    2505 Caminito Muirfield
    City
    La Jolla
    State
    CA
    ZIP
    92037
    Country
    US
    Email
    [email protected]
    Phone
    808 2844774

    Products

    Device Name Product Code
    System, Measurement, Blood-Pressure, Non-Invasive DXN

    Proprietary Names

    Hilo Cuff G0 Blood Pressure Monitoring System

    Establishment Types

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