BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HEALGEN LIFE SCIENCE LLC

    Reg #: 3038371335 · FEI: 3038371335 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    HEALGEN LIFE SCIENCE LLC
    Registration Number
    3038371335
    FEI Number
    3038371335
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    3818 Fuqua St
    City
    Houston
    State
    TX
    ZIP
    77047
    Country
    US

    Regulatory Submissions

    510(k) Number
    K251972

    Owner / Operator

    Firm Name
    Healgen Life Science LLC
    Operator Number
    10093264
    Address
    3818 Fuqua St
    City
    Houston
    State
    TX
    Postal Code
    77047
    Country
    US
    Correspondent
    Jianqiu Fang

    Products

    Device Name Product Code
    Fluorometer, For Clinical Use KHO
    Enzyme Immunoassay, Opiates DJG
    Control, Fecal Occult Blood OSL

    Proprietary Names

    Healgen AccuFluor Fentanyl Fluorescence Immunoassay (FIA) Test Kit - Qualitative Healgen Immunofluorescence Analyzer OG-H180

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility