BEUDAMED
    FDA Registration Active 🇫🇷 France

    Insulia Diabetes Management Companion

    Reg #: 3013530341 · FEI: 3013530341 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Voluntis
    Registration Number
    3013530341
    FEI Number
    3013530341
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    12-14 Rue Louis Bleriot
    City
    Rueil-Malmaison Hauts-de-Seine
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K161433

    Owner / Operator

    Firm Name
    Voluntis
    Operator Number
    10053592
    Address
    58 avenue de Wagram
    City
    Paris
    State
    FR-75
    Postal Code
    75017
    Country
    FR
    Correspondent
    Raffi Krikorian

    US Agent

    Business Name
    Aptar Digital Health
    Contact Name
    Kevin Howard
    Address
    245 Main Street, 2nd Floor
    City
    Cambridge
    State
    MA
    ZIP
    02142
    Country
    US
    Email
    [email protected]
    Phone
    617 2454119

    Products

    Device Name Product Code
    Calculator, Drug Dose NDC

    Proprietary Names

    Insulia Diabetes Management Companion

    Establishment Types

    Manufacture Medical Device