BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Agendia NV

    Reg #: 3017845262 · FEI: 3017845262 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Agendia NV
    Registration Number
    3017845262
    FEI Number
    3017845262
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Radarweg 60
    City
    Amsterdam Noord-Holland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K201902

    Owner / Operator

    Firm Name
    AGENDIA Inc.
    Operator Number
    9101719
    Address
    Agendia Inc., 22 Morgan
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Melissa Chavis

    US Agent

    Business Name
    Agendia Inc.
    Contact Name
    Melissa Chavis
    Address
    22 Morgan
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    858 7223685

    Products

    Device Name Product Code
    Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer NYI
    Container, Specimen Mailer And Storage, Non-Sterile NNK

    Proprietary Names

    MammaPrint® FFPE Agendia Specimen Collection Kit

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility