BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    DiaMed GmbH

    Reg #: 3004910133 · FEI: 3004910133 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    39
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    DiaMed GmbH
    Registration Number
    3004910133
    FEI Number
    3004910133
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Pra Rond 23
    City
    Cressier Fribourg
    Country
    CH

    Regulatory Submissions

    510(k) Number
    BK190388

    Owner / Operator

    Firm Name
    DiaMed GmbH (Bio-Rad Laboratories)
    Operator Number
    10032616
    Address
    Pra Rond 23
    City
    Cressier
    State
    Fribourg
    Postal Code
    1785
    Country
    CH
    Correspondent
    Jeremy Poropane

    US Agent

    Business Name
    Bio-Rad Laboratories
    Contact Name
    David Bhend
    Address
    6565 185th Ave Ne
    City
    Redmond
    State
    WA
    ZIP
    98052
    Country
    US
    Email
    [email protected]
    Phone
    425 4981758

    Products

    Device Name Product Code
    System, Test, Automated Blood Grouping And Antibody KSZ
    Kit, Quality Control For Blood Banking Reagents KSF
    Manual Blood Grouping And Antibody Test Systems PBC
    Diluent, Blood Cell GIF
    Media, Potentiating For In Vitro Diagnostic Use KSG
    Solution, Stabilized Enzyme KSK
    Blood Establishment Computer Software And Accessories MMH

    Proprietary Names

    TANGO infinity IH-Basic QC IH-Incubator L Washing Solution Concentrate IH-500 Coombscell-E MLB2 Seraclone Control ABO+Rh Wash Solution A Concentrate Erytype S Rh Donor Erytype S Rh Donor Confirmation MLB 2 Solidscreen II Solidscreen II Negative Control Solidscreen II Control Erytype S ABO Donor Bromelin Bromelin for Erytype Solidscreen II Strip Negative Control Erytype S ABO Donor Confirmation Erytype S ABD+Rev. A1,B IH-Reader 24 Alsevers Solution Solidscreen II Control B Erytype S Rh+K Type IH-LISS Solution IH-Titration Solution IH-LISS Rack IH-Titration Rack IH-Papain IH-Card ABO Neutral IH-Com IH-Card Control IH-Internal QC IH-AbID IH-Centrifuge L IH-Card Neutral IH-1000

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198