BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GEL-X LLC

    Reg #: 3015729128 · FEI: 3015729128 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    GEL-X LLC
    Registration Number
    3015729128
    FEI Number
    3015729128
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    251 Little Falls Dr
    City
    Wilmington
    State
    DE
    ZIP
    19808
    Country
    US

    Regulatory Submissions

    510(k) Number
    K110102

    Owner / Operator

    Firm Name
    GEL-X LLC
    Operator Number
    10060658
    Address
    251 Little Falls Drive
    City
    Wilmington
    State
    DE
    Postal Code
    19808
    Country
    US
    Correspondent
    Andreas Brown

    Products

    Device Name Product Code
    Polymer Patient Examination Glove LZA
    Latex Patient Examination Glove LYY

    Proprietary Names

    ALLOGEL

    Establishment Types

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