BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    ETI-MAX 3000TM Analyzer

    Reg #: 9610240 · FEI: 3002808212 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    DiaSorin Italia S.p.A.
    Registration Number
    9610240
    FEI Number
    3002808212
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    VIA CRESCENTINO, snc
    City
    SALUGGIA Vercelli
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K052794

    Owner / Operator

    Firm Name
    DiaSorin Inc.
    Operator Number
    9051149
    Address
    1951 Northwestern Ave
    City
    Stillwater
    State
    MN
    Postal Code
    55082
    Country
    US
    Correspondent
    Mari Meyer

    US Agent

    Business Name
    DiaSorin Inc.
    Contact Name
    Mari Meyer
    Address
    1951 Northwestern Ave
    City
    Stillwater
    State
    MN
    ZIP
    55082
    Country
    US
    Email
    [email protected]
    Phone
    651 4939971

    Products

    Device Name Product Code
    Analyzer, Chemistry, Micro, For Clinical Use JJF

    Proprietary Names

    ETI-MAX 3000TM Analyzer ETI-MAX 3000 (TM) Analyzer Operating Software

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device