BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound Syste

    Reg #: 3009077524 · FEI: 3009077524 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    DHL SUPPLY CHAIN (NETHERLANDS) B.V.
    Registration Number
    3009077524
    FEI Number
    3009077524
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Zwenkgras 9
    City
    Beringe Limburg
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K201012

    Owner / Operator

    Firm Name
    DHL Supply Chain (Netherlands) B.V.
    Operator Number
    10085309
    Address
    Zwenkgras 15
    City
    Beringe
    State
    Noord-Brabant
    Postal Code
    5986 PM
    Country
    NL
    Correspondent
    QHSE Beringe

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Automated Radiological Image Processing Software QIH

    Proprietary Names

    EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound Syste

    Establishment Types

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