BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    MIRIS AB

    Reg #: 3013887826 · FEI: 3013887826 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    MIRIS AB
    Registration Number
    3013887826
    FEI Number
    3013887826
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Danmarksgatan 26
    City
    Uppsala
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K223085

    Owner / Operator

    Firm Name
    Miris AB
    Operator Number
    10059205
    Address
    Danmarksgatan 26
    City
    Uppsala
    State
    SE-C
    Postal Code
    75323
    Country
    SE

    US Agent

    Business Name
    mdi Consultants Inc
    Contact Name
    Alan Schwartz
    Address
    55 Northern Blvd
    City
    Great Neck
    State
    NY
    ZIP
    11021
    Country
    US
    Email
    [email protected]
    Phone
    516 4829001

    Products

    Device Name Product Code
    Breast Milk Macronutrients Test System QEI
    Multi-Analyte Controls Unassayed OHQ

    Proprietary Names

    Miris Human Milk Analyzer (HMA) Miris Calibration Control Kit Miris Human Milk Analyzer

    Establishment Types

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