BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Teladoc Health Blood Glucose Monitoring System

    Reg #: 3012391774 · FEI: 3012391774 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    22
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    Teladoc Health, Inc.
    Registration Number
    3012391774
    FEI Number
    3012391774
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    560 S Winchester Blvd, Suite 400
    City
    San Jose
    State
    CA
    ZIP
    95128
    Country
    US

    Regulatory Submissions

    510(k) Number
    K133584

    Owner / Operator

    Firm Name
    Teladoc Health, Inc.
    Operator Number
    10047465
    Address
    560 S WINCHESTER BLVD, Suite 400
    City
    San Jose
    State
    CA
    Postal Code
    95128
    Country
    US
    Correspondent
    Jacob Gendler

    Products

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

    Proprietary Names

    Teladoc Health Blood Glucose Monitoring System Teladoc Health Blood Glucose Test Strips Livongo Blood Glucose Test Strips Livongo Lancets Livongo DMS Livongo BGMS Livongo Blood Glucose Meter Teladoc Health Control Solution Teladoc Health Strips Livongo Blood Glucose Monitoring System Teladoc Health Data Management System Teladoc Health Lancing Device Teladoc Health DMS Teladoc Health Blood Glucose Meter Teladoc Health Lancets Livongo Data Management System Livongo Strips Livongo Control Solution Livongo Meter Livongo Lancing Device Teladoc Health Meter Teladoc Health BGMS

    Establishment Types

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