BEUDAMED
    FDA Registration Active 🇺🇸 United States

    VIVALNK, INC.

    Reg #: 3011651103 · FEI: 3011651103 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    18
    Establishment Types
    4
    Classifications
    5

    Registration Details

    Registration Name
    VIVALNK, INC.
    Registration Number
    3011651103
    FEI Number
    3011651103
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    51 EAST CAMPBELL AVE., SUITE 160
    City
    Campbell
    State
    CA
    ZIP
    95008
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191870

    Owner / Operator

    Firm Name
    VivaLnk Inc
    Operator Number
    10049171
    Address
    51 EAST CAMPBELL AVE., SUITE 160
    City
    Campbell
    State
    CA
    Postal Code
    95008
    Country
    US
    Correspondent
    quoi v huynh

    Products

    Device Name Product Code
    Tape And Bandage, Adhesive KGX
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Continuous Measurement Thermometer FLL
    Oximeter DQA
    System, Measurement, Blood-Pressure, Non-Invasive DXN

    Proprietary Names

    Temperature Adhesive Disposable Hydrogel Adhesive Fever Scout Adhesive Hydrogel Adhesive VivaLNK Adhesive Patch VV330 Continuous ECG Platform VV330 Continuous ECG Recorder VV350 Continuous ECG Platform VV350 Continuous ECG Recorder VV360 Continuous ECG Recorder VV360 Continuous ECG Platform Fever Scout Continuos monitoring thermometer Continuos monitoring thermometer Continuos monitoring thermometer - VV200 Oxyfit Electronic Blood pressure monitor cuff BP5S Infrared Thermometer Checkme O2/SpO2oxiband sleepmonitor

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device