BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DataTherm II Continuous Temperature Monitor

    Reg #: 1835242 · FEI: 1000518606 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    R.G. ENTERPRISES (U.S.A.), INC.
    Registration Number
    1835242
    FEI Number
    1000518606
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    26010 Pinehurst Dr
    City
    Madison Heights
    State
    MI
    ZIP
    48071
    Country
    US

    Regulatory Submissions

    510(k) Number
    K070878

    Owner / Operator

    Firm Name
    R.G. ENTERPRISES (U.S.A.), INC.
    Operator Number
    9024233
    Address
    26010 Pinehurst Dr
    City
    Madison Heights
    State
    MI
    Postal Code
    48071
    Country
    US
    Correspondent
    Ryder Stagg

    Products

    Device Name Product Code
    Continuous Measurement Thermometer FLL

    Proprietary Names

    DataTherm II Continuous Temperature Monitor

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device