BEUDAMED
    FDA Registration Active 🇺🇸 United States

    UE LIFESCIENCES INC.

    Reg #: 3010914393 · FEI: 3010914393 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

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    Registration Details

    Registration Name
    UE LIFESCIENCES INC.
    Registration Number
    3010914393
    FEI Number
    3010914393
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3675 Market St Ste 200
    City
    Philadelphia
    State
    PA
    ZIP
    19104
    Country
    US

    Regulatory Submissions

    510(k) Number
    K142926

    Owner / Operator

    Firm Name
    UE LifeSciences Inc.
    Operator Number
    10044277
    Address
    3401 Market St, Suite 200
    City
    Philadelphia
    State
    PA
    Postal Code
    19104
    Country
    US
    Correspondent
    Mihir Shah

    Products

    Device Name Product Code
    System, Documentation, Breast Lesion NKA
    System, Telethermographic (Adjunctive Use) LHQ

    Proprietary Names

    iBreastExam iBreastExam Gen2

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility