BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Beckman Coulter GmbH

    Reg #: 3002721051 · FEI: 3002721051 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    96
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Beckman Coulter GmbH
    Registration Number
    3002721051
    FEI Number
    3002721051
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Europark Fichtenhain B 13
    City
    Krefeld North Rhine-Westphalia
    Country
    DE

    Owner / Operator

    Firm Name
    BECKMAN COULTER, INC.
    Operator Number
    2050012
    Address
    250 S. Kraemer Blvd, --
    City
    Brea
    State
    CA
    Postal Code
    92821
    Country
    US

    US Agent

    Business Name
    Beckman Coulter, Inc.
    Contact Name
    Ian Pilcher
    Address
    1000 Lake Hazeltine Dr
    City
    Chaska
    State
    MN
    ZIP
    55318
    Country
    US
    Email
    [email protected]
    Phone
    443 3506459

    Products

    Device Name Product Code
    Products, Red-Cell Lysing Products GGK
    General Purpose Reagent PPM
    Diluent, Blood Cell GIF
    Detergent JCB

    Proprietary Names

    PerFix NC Kit (Lysing Reagent) IRIS BODY FLUIDS LYSING REAGENT AQUIOS Lysing Reagent Kit Fixative Solution (10X) OptiLyse C : Lysing Solution Lysing Solution (10X) IntraPrep Reagent 2: Permeabilization IOTest 3 Fixative VersaLyse : Lysing Solution IOTest 3 Lyse DxH 500 Series Lyse (PN B36846) Whole Blood Lysing Reagent COULTER Rinsol Cleaning Agent DxH Cell Lyse 1L & 5L AcT 5diff Fix DxH Retic Pack IMMUNOPREP REAGENT DxH diff Pack AcT 5diff Hgb Lyse COULTER DxH Cell Lyse DxH ECO Cell Lyse (5L) AcT 5diff WBC Lyse Access Red Blood Cell Folate Lysing Agent DxH ECO Cell Lyse (1L) Access Red Blood Cell Folate Lysing Agent (P/N: A14206 CA MFG) PerFix NC Kit (Fixative Reagent) 447420 IMMAGE Immunochemistry Systems BUF 4 Buffer 4 A28945 SYNCHRON Systems ISE Electrolyte Buffer 657133 Cartridge Chemistry Wash Solution (CCWA 2 x 300) UniCel DxI Wash Buffer II OnBoard Dilution Kit (A79784 MN MFG) 445865 SYNCHRON Systems Wash Concentrate II 472137 SYNCHRON and AU Systems Hemolyzing Reagent 447650 IMMAGE Immunochemistry Systems BUF 1 Buffer 1 Iris® System Cleanser Pack (800-3203) 447050 IMMAGE Immunochemistry Systems BUF 3 Buffer 3 447040 IMMAGE Immunochemistry Systems BUF 2 Buffer 2 598190 598190 Trace-Klean Ready to Use Cleaning Solution 447660 IMMAGE Immunochemistry Systems DIL 2 Diluent 2 589784 Trace-Klean Concentrated Cleaning Solution A28937 SYNCHRON Systems ISE Electrolyte Reference A88469 HbDIL DxC iChem® VELOCITY™ Wash Solution Case of 2 x 7L (800-7217) Iris® Diluent Pack (800-3202) 467826 Sample Diluent 1 DIL1 447640 IMMAGE Immunochemistry Systems DIL 1 Diluent 1 469110 Synchron Systems NO FOAM 447060 IMMAGE Immunochemistry Systems Wash Solution 445967 SYNCHRON CX Systems Antifoam 442831 PVT 2, 472055 PVT 5, 442830 PVT 3 DTCS Quick Start Kit DNA Size Standard Kit - 400 DNA Size Standard Kit - 600 Separation Buffer SEPARATION GEL-LPA I CEQ Sample Loading Solution Separation Gel – LPAI DNA Sequencing Separation Buffer Sample Loading Solution (SLS) DNA Size Standard Kit - 80 GenomeLab GeXP Start Kit iQ Body Fluids Lysing Reagent (800-3213) iQ Lamina 2 x 7L (800-3236) iQ Body Fluids Conical Tubes (800-3215) 66039 Cleaning Solution 664090 CLENZ Solution Access Wash Buffer II ( P/N: A16972 KY and DE MFG) Access Substrate (P/N: 81906 MN MFG) Flow Check Pro Fluorospheres UniCel DxI Access Wash Buffer II (P/N: A16973 KY and DE MFG) Access Sample Diluent A (P/N: 81908 MN MFG) FLOW-CHECK Access Sample Diluent A (Onboard Reagent Kit) (P/N: A79783 MN MFG) LumiPhos PRO Substrate (P/N: B96000 MN MFG) DxFLEX Daily QC Fluorospheres ODR2000 5L WASH SOLUTION OSR62166 LIH OSR0001 WASH SOLUTION 657197 Synchron AUTO-GLOSS CTS AQUIOS Sheath Solution DxFLEX Sheath Fluid ISOFLOW Sheath Fluid AcT 5diff Diluent DxH 500 Series Diluent (PN B36845) DxH Diluent DxH Concentrated ECO Diluent DxH ECO Diluent AQUIOS Sodium Hypochlorite Solution AQUIOS Cleaning Agent (PN B25698) DxH 500 Series Cleaner (PN 36868) DxH Cleaner AcT 5diff Rinse Flow Clean (PN A64669) CLENZ AQUIOS Cleaning Agent (PN C48097) Flow Clean (PN C48093)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)