BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TRUEfocus

    Reg #: 1000113657 · FEI: 1000113657 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    Trividia Health, Inc.
    Registration Number
    1000113657
    FEI Number
    1000113657
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2400 NW 55TH CT
    City
    Fort Lauderdale
    State
    FL
    ZIP
    33309
    Country
    US

    Regulatory Submissions

    510(k) Number
    K131013

    Owner / Operator

    Firm Name
    TRIVIDIA HEALTH, INC.
    Operator Number
    9000560
    Address
    2400 N.W. 55TH CT., --
    City
    Ft Lauderdale
    State
    FL
    Postal Code
    33309
    Country
    US
    Correspondent
    HEIDI - STRUNK

    Products

    Device Name Product Code
    System, Test, Blood Glucose, Over The Counter NBW
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Glucose Dehydrogenase, Glucose LFR

    Proprietary Names

    TRUEfocus TRUEfocus PRO

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device