BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Beckman Coulter Distribution B.V.

    Reg #: 3007750372 · FEI: 3007750372 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    Beckman Coulter Distribution B.V.
    Registration Number
    3007750372
    FEI Number
    3007750372
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Pelmolenlaan 15
    City
    Woerden Utrecht
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K181475

    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
    Counter, Differential Cell GKZ

    Proprietary Names

    DxH 520 Hematology Analyzer (B40602) DxH 500 Hematology Analyzer (B40601) DxH 560 Hematology Analyzer (B40603)

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device