BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Belzer UW® Cold Storage Solution

    Reg #: 1067143 · FEI: 3003750694 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BIOCURE SOLUTIONS, LLC DBA BIOCURE, INC.
    Registration Number
    1067143
    FEI Number
    3003750694
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2975 Gateway Dr
    City
    Peachtree Corners
    State
    GA
    ZIP
    30071
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243384

    Owner / Operator

    Firm Name
    BioCure Solutions, LLC dba BioCure, Inc.
    Operator Number
    10093191
    Address
    2975 Gateway Dr
    City
    Peachtree Corners
    State
    GA
    Postal Code
    30071
    Country
    US
    Correspondent
    Minh Vo

    Products

    Device Name Product Code
    System, Perfusion, Kidney KDN
    Set, Perfusion, Kidney, Disposable KDL

    Proprietary Names

    Belzer UW® Cold Storage Solution

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)