BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CLEVELAND DIAGNOSTICS, INC.

    Reg #: 3011015335 · FEI: 3011015335 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    CLEVELAND DIAGNOSTICS, INC.
    Registration Number
    3011015335
    FEI Number
    3011015335
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3615 Superior Ave Ste 4406a
    City
    Cleveland
    State
    OH
    ZIP
    44114
    Country
    US

    Regulatory Submissions

    PMA Number
    P200048

    Owner / Operator

    Firm Name
    Cleveland Diagnostics, Inc.
    Operator Number
    10095401
    Address
    3615 Superior Avenue, Suite 4406A
    City
    Cleveland
    State
    OH
    Postal Code
    44114
    Country
    US
    Correspondent
    Mark Muyinda

    Products

    Device Name Product Code
    Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer QRF

    Proprietary Names

    IsoPSA Assay

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Reprocess Single-Use Device