BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Genomadix Cube CYP2C19 System

    Reg #: 3021047648 · FEI: 3021047648 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    GENOMADIX INC
    Registration Number
    3021047648
    FEI Number
    3021047648
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    340 Legget Drive, Suite 180
    City
    Kanata (Ottawa) Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K220026

    Owner / Operator

    Firm Name
    Genomadix Inc
    Operator Number
    10088570
    Address
    340 Legget Drive, Suite 180
    City
    Kanata (Ottawa)
    State
    Ontario
    Postal Code
    K2K1Y6
    Country
    CA
    Correspondent
    Bern Johnson

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Drug Metabolizing Enzyme Genotyping Systems NTI

    Proprietary Names

    Genomadix Cube CYP2C19 System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device