BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CODONICS, INC.

    Reg #: 1530958 · FEI: 1000639866 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    14
    Establishment Types
    3
    Classifications
    6

    Registration Details

    Registration Name
    CODONICS, INC.
    Registration Number
    1530958
    FEI Number
    1000639866
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    17991 Englewood Dr
    City
    Middleburg Heights
    State
    OH
    ZIP
    44130
    Country
    US

    Regulatory Submissions

    510(k) Number
    K021054

    Owner / Operator

    Firm Name
    CODONICS, INC.
    Operator Number
    9026554
    Address
    17991 ENGLEWOOD DR., --
    City
    Middleburg Heights
    State
    OH
    Postal Code
    44130
    Country
    US
    Correspondent
    Vincent - Yee

    Products

    Device Name Product Code
    Camera, Multi Format, Radiological LMC
    Colorimeter, Photometer, Spectrophotometer For Clinical Use JJQ
    Device, Digital Image Storage, Radiological LMB
    System, Digital Image Communications, Radiological LMD
    Film, Radiographic IWZ
    Gas-Machine, Anesthesia BSZ

    Proprietary Names

    Horizon Multimedia Imager Ci Horizon Multimedia Imager G2 Horizon Multimedia Imager GS Horizon Multimedia Imager G1 Horizon Multimedia Long Film XL Safe Waste System (SWS) Spectrophotometer for Pharmaceutical Analysis Virtua C Medical Device Recorder Virtua E Medical Device Recorder Virtua Medical Image Disc Recorder Virtua XR Medical Image Disc Recorder Direct Vista Blue Blue Film,Direct Vista Blue-T(DVBT),Direct Vista Blue-5(DVB5) Direct Vista Clear,Direct Vista White Film,Chroma Vista White Film CODONICS SAFE LABELING SYSTEM (SLS) SLS-500i/550i/600i, SLS-500P, SLS-XXX, Point of Care Station (PCS) Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features)

    Establishment Types

    Remanufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device