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    FDA Registration Active 🇨🇳 China

    Respironics Medical Products (Shenzhen) Co., Ltd.

    Reg #: 3038562397 · FEI: 3038562397 · Expires 2026
    View on FDA
    Products
    16
    Proprietary Names
    90
    Establishment Types
    1
    Classifications
    16

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    Registration Details

    Registration Name
    Respironics Medical Products (Shenzhen) Co., Ltd.
    Registration Number
    3038562397
    FEI Number
    3038562397
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    101, 201, 301-B, Building 1, Park 1, Xin Qiao Dong Advanced Industrial Park, Hong Tian Community, Xin Qiao Sub-district, Bao An District,
    City
    Shenzhen Guangdong
    Country
    CN

    Owner / Operator

    Firm Name
    Philips Medical Systems International BV
    Operator Number
    2518422
    Address
    Veenpluis 6
    City
    Best
    State
    NL-NOTA
    Postal Code
    5684PC
    Country
    NL

    US Agent

    Business Name
    Philips
    Contact Name
    Tom Fallon
    Address
    1001 Murry Ridge Ln
    City
    Murrysville
    State
    PA
    ZIP
    15668
    Country
    US
    Email
    [email protected]
    Phone
    978 9415572

    Products

    Device Name Product Code
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Transducer, Gas Flow BXP
    Ventilator, Non-Continuous (Respirator) BZD
    Ventilator, Continuous, Facility Use CBK
    Nebulizer (Direct Patient Interface) CAF
    Connector, Airway (Extension) BZA
    Spirometer, Therapeutic (Incentive) BWF
    Automatic Event Detection Software For Polysomnograph With Electroencephalograph OLZ
    Standard Polysomnograph With Electroencephalograph OLV
    Holding Chambers, Direct Patient Interface NVP
    Calculator, Pulmonary Function Data BZC
    Meter, Peak Flow, Spirometry BZH
    Mouthpiece, Breathing BYP
    Attachment, Breathing, Positive End Expiratory Pressure BYE
    Sv70 Ventilator MNT
    Ventilator, Continuous, Non-Life-Supporting MNS

    Proprietary Names

    Patient Circuits CO2/Flow Sensor Adult CO2/Flow Sensor Pediatric CO2/Flow Sensor Neonatal Pediatric / Adult Combined CO2/Flow Sensor Series 3 Pediatric Combined CO2/Flow Sensor Series 3 Pediatric/Adult Flow Sensor Series 3 Neonatal Combined CO2/Flow Sensor Series 3 Neonatal Flow Sensor Series 3 Bronchoscopy Elbow AF531 Oro-Nasal SE Face Mask PerforMax Pediatric EE Total FFM - Leak 1 and 2 Sidestream Reusable Neb and Masks Comfort Gel Blue Nasal Mask Pediatric/Adult Airway Adapter with Mouthpiece Pediatric/Adult Airway Adapter 15mm Male/Female Adapter-Low Deadspace Neonatal/Pediatric Airway Adapter 15mm Male/Female Adapter Threshold Pep Threshold IMT ComfortGel Blue SE FFM Amara View SE FFM Amara View FFM - RIMR, RIMP ComfortFull FFM - RSZ Amara FFM - RIMR, RIMP Sleepware G3 Sleepware Alice 6 PSG Base Station LDE LDxN LDxS Alice 6 Headbox LDE LDx Alice PSG or components ECG wireset AF811 FFM ComfortGel Blue FFM OptiChamber Diamond with Lite Touch mask FloTrak CO2 Sensor Flow Sensor Sidestream Plus Pediatric Mask Sidestream Plus Adult Mask Sidestream Plus Nebulizer Dreamwear Silicone Pillows Mask AP111 EE/SE Nasal Mask Contour Deluxe/Comfort/Ptrak Nasal Mask Peak Flow Meter Asthma Check Asthma Mentor FFM PTrak FFM AF541 SE Full Face Mask AF531 Oro-Nasal EE Leak 1 Face Mask AF531 Oro-Nasal EE Leak 2 Face Mask Mouthpiece, Angled Disposable Angled Mouthpiece Reusable Mouthpiece Mouthpiece Straight Nuance and Nuance Pro Nasal Pillow Mask Wisp Youth Nasal Mask Shimmer Full Face Mask S/M/L/MW Dreamwear Full Med Frm w/HGR WhisperFlow Procedure Packs DreamWear Full Mask DreamWear Nasal Mask DreamWisp Nasal Mask PN841 Nasal Mask Wisp Pediatric Nasal Mask PN841 SE Nasal Mask Wisp Pediatric Nasal Mask SE Elbow Accessory Wisp Nasal Mask Wisp SE Nasal Mask Opti Chamber Valved Holding Chamber Bronchoscopy Elbow, Click Style Bronchoscopy elbow Performax Pediatric SE Total FFM Disposable/FEP/Invasive Circuits BiPAP Vision Sidestream Disposable Neb and Masks AF541 EE Leak 1 Full Face Mask AF541 EE Leak 2 Full Face Mask LiteTouch Mask Therapy Mask 3100 NC/SP TrueBlue Nasal Mask Pico SE Nasal Mask AF531 FFM AF541 FFM AF421 FFM AF531 SE Full Face Mask CPAP VALVES

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)