BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Telcare BGM

    Reg #: 3008514395 · FEI: 3008514395 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    Telcare, LLC
    Registration Number
    3008514395
    FEI Number
    3008514395
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    600 West Ridge Road, Suite 200
    City
    Upper Chichester
    State
    PA
    ZIP
    19061
    Country
    US

    Regulatory Submissions

    510(k) Number
    K110571

    Owner / Operator

    Firm Name
    Philips Medical Systems International BV
    Operator Number
    1217116
    Address
    Veenpluis 6
    City
    Best
    State
    NL-NOTA
    Postal Code
    5684PC
    Country
    NL

    Products

    Device Name Product Code
    Calculator/Data Processing Module, For Clinical Use JQP
    System, Test, Blood Glucose, Over The Counter NBW
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Glucose Oxidase, Glucose CGA

    Proprietary Names

    Telcare BGM BioTel Care BGM Telcare Cloud BioTel Care Blood Glucose Monitoring System Philips Ambulatory Virtual Care Blood Glucose Monitoring System Telcare Blood Glucose Monitoring System Telcare

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device