BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Cardiochek Bioscanner plus

    Reg #: 3002736372 · FEI: 3004631140 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    East West Wisconsin
    Registration Number
    3002736372
    FEI Number
    3004631140
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    640 N Prospect Dr
    City
    WHITEWATER
    State
    WI
    ZIP
    53190
    Country
    US

    Regulatory Submissions

    510(k) Number
    K151545

    Owner / Operator

    Firm Name
    East West
    Operator Number
    10058019
    Address
    4170 Ashford Dunwoody Rd, suite 560
    City
    Atlanta
    State
    GA
    Postal Code
    30319
    Country
    US
    Correspondent
    Frank Runner

    Products

    Device Name Product Code
    Ldl & Vldl Precipitation, Hdl LBR
    Enzymatic Esterase--Oxidase, Cholesterol CHH
    Colorimetric Method, Triglycerides JGY

    Proprietary Names

    Cardiochek Bioscanner plus

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)