BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AGAMATRIX

    Reg #: 3004637226 · FEI: 3004637226 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    4
    Classifications
    4

    Registration Details

    Registration Name
    AGAMATRIX
    Registration Number
    3004637226
    FEI Number
    3004637226
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    34 Route 111 Ste 100
    City
    Derry
    State
    NH
    ZIP
    03038
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241304

    Owner / Operator

    Firm Name
    AGAMATRIX
    Operator Number
    9078906
    Address
    34 Route 111 Suite 100, --
    City
    Derry
    State
    NH
    Postal Code
    03038
    Country
    US
    Correspondent
    Padmini Gagnon

    Products

    Device Name Product Code
    System, Test, Blood Glucose, Over The Counter NBW
    Glucose Oxidase, Glucose CGA
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK

    Proprietary Names

    AgaMatrix, Lancets

    Establishment Types

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