BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EKLA Infrared Forehead Thermometer; EDTT-1B, VDTT-1B

    Reg #: 3008733163 · FEI: 3008733163 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    EKLA CORPORATION
    Registration Number
    3008733163
    FEI Number
    3008733163
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1707 Quincy Ave Ste 127
    City
    Naperville
    State
    IL
    ZIP
    60540
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160802

    Owner / Operator

    Firm Name
    EKLA Corporation
    Operator Number
    10035863
    Address
    1707 Quincy Ave. Suite 127
    City
    Naperville
    State
    IL
    Postal Code
    60540
    Country
    US
    Correspondent
    Erin Lu

    Products

    Device Name Product Code
    Continuous Measurement Thermometer FLL

    Proprietary Names

    EKLA Infrared Forehead Thermometer; EDTT-1B, VDTT-1B

    Establishment Types

    Repack or Relabel Medical Device