BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Beacon Bio Dx, LLC dba CleveMed

    Reg #: 1530224 · FEI: 3000206198 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    Beacon Bio Dx, LLC dba CleveMed
    Registration Number
    1530224
    FEI Number
    3000206198
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4415 Euclid Avenue, Ste # 400
    City
    CLEVELAND
    State
    OH
    ZIP
    44103
    Country
    US

    Regulatory Submissions

    510(k) Number
    K042039

    Owner / Operator

    Firm Name
    Beacon Bio Dx,LLC dba CleveMed
    Operator Number
    9023591
    Address
    4415 EUCLID AVE., --
    City
    Cleveland
    State
    OH
    Postal Code
    44103
    Country
    US

    Products

    Device Name Product Code
    Full-Montage Standard Electroencephalograph GWQ
    Standard Polysomnograph With Electroencephalograph OLV
    Medical Device Data System OUG
    Tape And Bandage, Adhesive KGX

    Proprietary Names

    Sapphire PSG SleepView Sleep Scout SleepView Web Portal IDcheck

    Establishment Types

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