BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    Fisher & Paykel Healthcare S.A.de C.V.

    Reg #: 3008264065 · FEI: 3008264065 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    104
    Establishment Types
    1
    Classifications
    12

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    Registration Details

    Registration Name
    Fisher & Paykel Healthcare S.A.de C.V.
    Registration Number
    3008264065
    FEI Number
    3008264065
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Av. Todos los Santos #12831, Parque Industrial Pacifico
    City
    Tijuana Baja California
    Country
    MX

    Owner / Operator

    Firm Name
    FISHER & PAYKEL HEALTHCARE NZ LTD
    Operator Number
    8040217
    Address
    15 MAURICE PAYKEL PLACE
    City
    EAST TAMAKI, AUCKLAND
    State
    NZ-NOTA
    Postal Code
    2013
    Country
    NZ
    Correspondent
    Brian Schultz

    US Agent

    Business Name
    FISHER & PAYKEL LIMITED HEALTHCARE
    Contact Name
    Diego Vargas Banuelos
    Address
    17400 Laguna Canyon Road., SUITE 300, Irvine
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 4341005

    Products

    Device Name Product Code
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Ventilator, Non-Continuous (Respirator) BZD
    Sv70 Ventilator MNT
    Ventilator, Continuous, Facility Use CBK
    Mask, Oxygen BYG
    Tape And Bandage, Adhesive KGX
    Filter, Bacterial, Breathing-Circuit CAH
    High Flow/High Velocity Humidified Oxygen Delivery Device QAV
    Noninvasive Positive Airway Pressure System, Facility Use SGR
    Cannula, Nasal, Oxygen CAT
    Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer BZE
    Set, Tubing And Support, Ventilator (W Harness) BZO

    Proprietary Names

    Optiflow Junior 2/2+ Interface Range FlexiFit Series HC431 Flexifit Full Face Mask RT045XS/S/M/L RT055XS/S/M/L Eson Mask F&P Eson Nasal Mask OptiNIV F&P Eson 2 ESON2 Nasal Mask Fit Pack ESN2SML ESON2 Nasal Mask Fit Pack FlexiFit 407 (Sleep Lab) FlexiFit 407 FlexiFit 405 (Sleep Lab) Mask Oxygen MR290 Humidification Chamber Icon Heated Breathing Tube Infosmart Software package ICON+ Novo CPAP ICON+ Auto CPAP 900ICON208 ThermoSmart Breathing Tube InfoUSB2 Infosmart CD Oxygen Elbow SmartStick Net Icon Chamber ICON+ Premo CPAP DaisyDot Sensor Cover DaisyDot Mini Sensor Cover Optiflow Junior 2 WigglewiNG XS S Optiflow Junior 2 WigglewiNG XXL Optiflow Junior 2 WigglewiNG M L XL Visairo RT077 Visairo RT076 Visairo RT075 RT020 End Expiratory Filter RT047XS/S/M/L RT057XS/S/M/L Vitera Mask Dbl Seal Sml/Sml A Model Vitera Mask Full Face Small Sleep Lab Vitera Mask Full Face Large Sleep Lab Vitera Mask Dbl Seal Med/Med A Model Vitera Mask Full Face Medium A Model Vitera Mask Dbl Seal Lrg/Lrg A Model Vitera Mask Fitpack Sml/Med/Lrg A Model Vitera Mask Full Face Small A Model Vitera Mask Full Face Medium Sleep Lab Vitera Mask Full Face Med/Lrg Sleep Lab Vitera Mask myStart Pack Sml/Med/Lrg A Model Vitera Mask Full Face Large A Model Airvo 3 OptiPAP Junior Nasal cannula large Nasal cannula small Nasal cannula medium Optiflow+ nasal cannula Nasal cannula extra large Nasal cannula extra small RT oxygen cannula Optiflow oxygen cannula BC oxygen cannula 400473SL Forma Full Face Mask 400473A Forma Full Face Mask HC432 Flexifit Full Face Mask 400471A Forma Full Face Mask 400470A Forma Full Face Mask 400470SL Forma Full Face Mask 400471SL Forma Full Face Mask myAirvo Optiflow F&P Optiflow™ Nasal Oxygen Cannula with CO2 Sampling Optiflow Trace RT016 Filter RT280, 'Adult Evaqua 2' Dual Heated Breathing Circuit RT302 MicroCell Technology Heated Inspiratory Adult Breathing Circuit and Optiflow+ Nasal Cannula RT332, 'MicroCell Technology Heated Inspiratory Adult Breathing Circuit and Optiflow Nasal Cannula' RT232, 'Adult Optiflow Circuit Kit with MicroCell Technology RT481 Care Continuum Kit- Vent Use RT380 and RT385, 'Adult Evaqua 2' Dual Heated Breathing Circuits Inspiratory/Expiratory Filter RT046XS/S/M/L RT056XS/S/M/L MR850 Resipiratory Humidifier AirSpiral Heated Breathing Tube Optiflow Patient Interface 400475 F&P Simplus Full Face Mask - Small F&P Simplus Full Face Mask 400476 F&P Simplus Full Face Mask - Medium 400477 F&P Simplus Full Face Mask - Large F&P Simplus Full Face Mask SL - Small F&P Simplus Full Face Mask SL - Large F&P Simplus Full Face Mask SL - Medium 400483FITPACK SIMPLUS Full Face Mask Fit Pack SML SIMPLUS Full Face Mask Fit Pack SML Tube Bonnet BC3020-10 Chin Strap Mask interface adaptor Head Gear Chamber Connector ADAPTOR KITS MIDLINE PATIENT INTERFACE MR850 Respiratory Humidifier

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)