BEUDAMED
    EU Manufacturer ๐Ÿ‡บ๐Ÿ‡ธ United States Active

    Beckman Coulter Inc.

    SRN: US-MF-000010288 ยท S Kraemer Blvd 250, 92821 Brea, CA, United States
    View on EUDAMED
    Basic UDI-DIs
    975
    Total Devices
    1166
    On Market
    1157
    Off Market
    9
    Certificates
    24
    Valid
    0
    Expiring < 6mo
    0
    Countries
    32

    Basic Information

    Address
    S Kraemer Blvd 250, 92821 Brea, CA, United States
    Email
    [email protected]
    Phone
    +(1) 800-854-3633
    Website
    beckmancoulter.com

    Regulatory Overview

    Regulation
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    Eu Ivdd 601
    Eu Ivdr 374
    Classification
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    Eu Ivd General 547
    Eu Ivd Class B 195
    Eu Ivd Class C 94
    Eu Ivd Class A 85
    Eu Ivd Annex 2 List B 38
    Eu Ivd Annex 2 List A 16
    Device Types
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    Certificate Health

    Total
    24
    Valid
    0
    Expiring < 6mo
    0
    Expired / Withdrawn
    24
    Certificates by Expiry Year
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    Type Number Expiry Date Status
    IVDD Annex IV (excluding sections 4, 6) 668398 Sep 14, 2022
    IVDD Annex V 7981 May 26, 2024
    IVDD Annex V 7977 May 26, 2024
    IVDD Annex V 8021 May 26, 2024
    IVDD Annex IV Section 4 765852 May 26, 2025
    IVDD Annex IV (excluding sections 4, 6) CE 668398 May 26, 2025
    IVDD Annex IV (excluding sections 4, 6) 10998 May 26, 2025
    IVDD Annex VII (excluding section 5) 10997 May 26, 2025
    IVDD Annex V 10776 May 26, 2025
    IVDD Annex V 10773 May 26, 2025
    IVDD Annex V 8309 May 26, 2025
    IVDD Annex V 8942 May 26, 2025
    IVDD Annex V 8941 May 26, 2025
    IVDD Annex V 8571 May 26, 2025
    IVDD Annex V 8906 May 26, 2025
    IVDD Annex V 8900 May 26, 2025
    IVDD Annex V 10769 May 26, 2025
    IVDD Annex V 7993 May 26, 2025
    IVDD Annex V 8940 May 26, 2025
    IVDD Annex V 8939 May 26, 2025
    IVDD Annex V 8938 May 26, 2025
    IVDD Annex V 8897 May 26, 2025
    IVDD Annex V 8922 May 26, 2025
    IVDD Annex V 8921 May 26, 2025

    Market Presence

    Devices from this manufacturer are available in 32 countries across Europe.

    ๐Ÿ‡ฆ๐Ÿ‡น Austria ๐Ÿ‡ง๐Ÿ‡ช Belgium ๐Ÿ‡ง๐Ÿ‡ฌ Bulgaria ๐Ÿ‡จ๐Ÿ‡พ Cyprus ๐Ÿ‡จ๐Ÿ‡ฟ Czechia ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฉ๐Ÿ‡ฐ Denmark ๐Ÿ‡ช๐Ÿ‡ช Estonia ๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ซ๐Ÿ‡ฎ Finland ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ญ๐Ÿ‡ท Croatia ๐Ÿ‡ญ๐Ÿ‡บ Hungary ๐Ÿ‡ฎ๐Ÿ‡ช Ireland ๐Ÿ‡ฎ๐Ÿ‡ธ Iceland ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ฑ๐Ÿ‡ฎ Liechtenstein ๐Ÿ‡ฑ๐Ÿ‡น Lithuania ๐Ÿ‡ฑ๐Ÿ‡บ Luxembourg ๐Ÿ‡ฑ๐Ÿ‡ป Latvia ๐Ÿ‡ฒ๐Ÿ‡น Malta ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands ๐Ÿ‡ณ๐Ÿ‡ด Norway ๐Ÿ‡ต๐Ÿ‡ฑ Poland ๐Ÿ‡ต๐Ÿ‡น Portugal ๐Ÿ‡ท๐Ÿ‡ด Romania ๐Ÿ‡ธ๐Ÿ‡ช Sweden ๐Ÿ‡ธ๐Ÿ‡ฎ Slovenia ๐Ÿ‡ธ๐Ÿ‡ฐ Slovakia ๐Ÿ‡น๐Ÿ‡ท Tรผrkiye ๐Ÿ‡ฌ๐Ÿ‡ง United Kingdom

    Device Portfolio

    Name
    Access 2 Immunoassay System
    Access Red Blood Cell Folate Lysing Agent
    IOTest MsIgG1-PC7
    MicroScan Neg Combo 82
    Total Bilirubin
    "Access Sample Diluent A (Onboard Reagent Kit)"
    "UniCel DxI Access Wash Buffer II"
    "UniCel DxI Wash Buffer II"
    ACCESS SARS-CoV-2 IgM (reagent pack)
    ACCESS SARS-CoV-2 IgM Calibrators
    ACCESS SARS-CoV-2 IgM QC
    ALKALINE PHOSPHATASE
    ALKALINE PHOSPHATASE
    ALKALINE PHOSPHATASE
    ALKALINE PHOSPHATASE
    ALT
    ALT
    ALT
    APC (675/633) Setup Kit
    APO A1
    APO B
    APO CAL Apolipoprotein Calibrator
    APO CAL Apolipoprotein Calibrator
    AST
    AST
    AST
    AST
    AUTOSAMPLERS
    AVANTI J-15R, 120 VAC IVD
    AVANTI J-15R, 200-230 VAC IVD
    AVANTI Jโ€15R, 208โ€230 VAC, IVD
    AcT 5 diff OV
    Access 1 mL/13mm Insert Cup Caps
    Access 1 mL/13mm Insert Cups
    Access 16 mm (Insert Cups)
    Access 2 Module, DxC 500i
    Access 2 mL Sample Cups
    Access 25(OH) Vitamin D Total (Reagent Pack)
    Access 25(OH) Vitamin D Total Calibrators
    Access 25(OH) Vitamin D Total Calibrators
    Access 25(OH) Vitamin D Total Calibrators For Use on the Access 2 Immunoassay System
    Access 25(OH) Vitamin D Total Calibrators For Use on the UniCel DxI Immunoassay System
    Access 25(OH) Vitamin D Total For Use on the Access 2 Immunoassay System
    Access 25(OH) Vitamin D Total For Use on the UniCel DxI Immunoassay System
    Access 25(OH) Vitamin D Total Reagent Pack
    Access 25(OH) Vitamin D Total Reagent Pack
    Access 3 mL Container Caps (Blue)
    Access AFP (100 & 200 Test)(Reagent Pack)
    Access AFP (100 & 200 Test)(Reagent Pack)
    Access AFP (100 Test Reagent Pack)
    View all 1166 devices โ†’