BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Bilisoft 2 Phototherapy System, Small Pad

    Reg #: 1000122810 · FEI: 1000122810 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Lumitex Medical Devices, Inc.
    Registration Number
    1000122810
    FEI Number
    1000122810
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6611 W Snowville Rd
    City
    Brecksville
    State
    OH
    ZIP
    44141
    Country
    US

    Regulatory Submissions

    510(k) Number
    K053568

    Owner / Operator

    Firm Name
    Lumitex Medical Devices, Inc.
    Operator Number
    9000093
    Address
    6611 W Snowville Rd, --
    City
    Brecksville
    State
    OH
    Postal Code
    44141
    Country
    US
    Correspondent
    Kimberly S Tetuan

    Products

    Device Name Product Code
    Unit, Neonatal Phototherapy LBI

    Proprietary Names

    Bilisoft 2 Phototherapy System, Small Pad Bilisoft 2 Phototherapy System, English Large Pad Bilisoft Phototherapy System Bilisoft 2 Phototherapy System, English Small Pad Bilisoft 2 Phototherapy System, Large Pad

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device