BEUDAMED
    FDA Registration Active 🇺🇸 United States

    iXensor USA Inc

    Reg #: 3017548799 · FEI: 3017548799 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    4

    Research this establishment in seconds

    The Research Assistant profiles FDA-registered establishments — listings, owners, related facilities — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Registration Details

    Registration Name
    iXensor USA Inc
    Registration Number
    3017548799
    FEI Number
    3017548799
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    29122 Rancho Viejo Rd Ste 212
    City
    San Juan Capistrano
    State
    CA
    ZIP
    92675
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192369

    Owner / Operator

    Firm Name
    iXensor Co Ltd
    Operator Number
    10048224
    Address
    11492 6F., No.9, Aly. 2, Ln. 35, Jihu Rd.,, Neihu Dist,
    City
    Taipei
    State
    TW-TPE
    Postal Code
    114
    Country
    TW

    Products

    Device Name Product Code
    Test, Luteinizing Hormone (Lh), Over The Counter NGE
    Assay, Glycosylated Hemoglobin LCP
    System, Test, Blood Glucose, Over The Counter NBW
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE

    Proprietary Names

    Eveline PixoTest CVSHealth

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198