BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Thermal Regulating System

    Reg #: 1836518 · FEI: 3003261020 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    3T Medical Systems Inc.
    Registration Number
    1836518
    FEI Number
    3003261020
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    236 Fernwood Ave
    City
    Edison
    State
    NJ
    ZIP
    08837
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180834

    Owner / Operator

    Firm Name
    3T MEDICAL SYSTEMS, Inc
    Operator Number
    9043935
    Address
    236 Fernwood Ave
    City
    Edison
    State
    NJ
    Postal Code
    08837
    Country
    US
    Correspondent
    Erica Franco

    Products

    Device Name Product Code
    Continuous Measurement Thermometer FLL
    System, Thermal Regulating DWJ

    Proprietary Names

    Thermal Regulating System

    Establishment Types

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