BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    ZOLL International Holding B.V.

    Reg #: 3029871637 · FEI: 3029871637 · Expires 2026
    View on FDA
    Products
    25
    Proprietary Names
    43
    Establishment Types
    1
    Classifications
    25

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    Registration Details

    Registration Name
    ZOLL International Holding B.V.
    Registration Number
    3029871637
    FEI Number
    3029871637
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Einsteinweg 8A
    City
    Elst Gelderland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K170533
    PMA Number
    P160033

    Owner / Operator

    Firm Name
    ZOLL Medical Corporation
    Operator Number
    1220908
    Address
    269 MILL ROAD
    City
    Chelmsford
    State
    MA
    Postal Code
    01824
    Country
    US
    Correspondent
    Paul Dias

    US Agent

    Business Name
    ZOLL MEDICAL CORPORATION
    Contact Name
    Paul Dias
    Address
    269 Mill Rd
    City
    Chelmsford
    State
    MA
    ZIP
    01824
    Country
    US
    Email
    [email protected]
    Phone
    978 4219413

    Products

    Device Name Product Code
    Automated External Defibrillators (Non-Wearable) MKJ
    Pump, Portable, Aspiration (Manual Or Powered) BTA
    Oximeter DQA
    Ventilator, Continuous, Facility Use CBK
    Kit, First Aid, Talking OVR
    Compressor, Cardiac, External DRM
    System, Hypothermia, Intravenous, Cooling NCX
    Display, Cathode-Ray Tube, Medical DXJ
    System, Oxygen, Aqueous MWG
    Transducer, Gas Flow BXP
    Spirometer, Therapeutic (Incentive) BWF
    Sleeve, Limb, Compressible JOW
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Continuous Measurement Thermometer FLL
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Electrocardiograph DPS
    Computer, Blood-Pressure DSK
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Mattress, Water, Temperature Regulated FOH
    Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve PIZ
    Cart, Emergency, Cardiopulmonary (Excluding Equipment) BZN
    Hyperthermia Monitor NZE
    System, Thermal Regulating DWJ
    Strap, Head, Gas Mask BTK

    Proprietary Names

    Eagle II EMV+ 731 Series Z Vent AEV Autopulse Resuscitation System Model 100 ICY Intravascular Heat Exchange Catheter Coolgard 3000 Console Cool Line Intravascular Heat Exchange Catheter Solex 7 Intravascular Heat Exchange Catheter Quattro Intravascular Heat Exchange Catheter Start-Up Kit Thermogard XP Console ZOLL Code Writer TherOx SSO2 Catheter TherOx DownStream Console TherOx DownStream Cartridge TherOx DownStream Console, Refurbished ACCUVENT SENSOR DISPOSABLE FLOWTUBE, ACCUVENT FLOW SENSOR CONNECTOR, ACCUVENT InnerCool STx+ Surface Pads Set MRI Roll Stand Roll Stand Thermogard Vest S/M Thermogard HQ Thermogard XP Temperature Management System Thermogard Surface System Surface Start-Up Kits Surface Temperature Management System Thermogard XP Refurbished STx Vest L/XL Thermogard HQ Refurbished Thermogard XP STx Surface Pads Thermogard HQ Temperature Management System Thermogard HQ Surface Start-Up Kit (TGHQ-SURF) STx Vest S/M Thermogard Vest L/XL STx Surface Pad Surface Start-Up Kit (CG-SURF) Solex Intravascular Heat Exchange Catheter Thermogard HQ Console

    Establishment Types

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