BEUDAMED
    FDA Registration Active 🇨🇳 China

    Philips (China) Investment Co., Ltd. Philips Healthcare - Shanghai CDC

    Reg #: 3012027770 · FEI: 3012027770 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    101
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    Philips (China) Investment Co., Ltd. Philips Healthcare - Shanghai CDC
    Registration Number
    3012027770
    FEI Number
    3012027770
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Building A1, #718 Lingshi Road, JingAn District
    City
    SHANGHAI
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K221141

    Owner / Operator

    Firm Name
    Philips Medical Systems International BV
    Operator Number
    1217116
    Address
    Veenpluis 6
    City
    Best
    State
    NL-NOTA
    Postal Code
    5684PC
    Country
    NL

    US Agent

    Business Name
    Philips
    Contact Name
    Deborah Currlin
    Address
    222 Jacobs Street
    City
    Cambridge
    State
    MA
    ZIP
    02141
    Country
    US
    Email
    [email protected]
    Phone
    858 9452753

    Products

    Device Name Product Code
    Electrocardiograph DPS
    Electrocardiograph, Ambulatory (Without Analysis) MWJ
    Computer, Diagnostic, Programmable DQK
    Electrocardiograph, Ambulatory, With Analysis Algorithm MLO
    Electrode, Electrocardiograph DRX
    Cable, Electrode IKD

    Proprietary Names

    12-Lead Patient Cables: 989803184921, 989803184931, 989803184941, 989803184951 PageWriter TC35 Cardiograph, TC35 (860437) DigiTrak XT Holter Recorder w/Leadwires DL950 Holter System ST80i Stress Test System w/ Printer, Lead Sets, Electrodes 989803180131, ST80i 12-Lead Complete Lead Set (IEC), Standard Length, Grabber 989803180141, ST80i 12-Lead Complete Lead Set (AAMI), Standard Length, Snaps 989803180121, ST80i 12-Lead Complete Lead Set (AAMI), Standard Length, Grabber 989803180151, ST80i 12-Lead Complete Lead Set (IEC), Standard Length, Snaps ST80i Stress Test System PageWriter TC20, TC30, TC50, TC70 w/PIM, Lead Sets, Adapters, Electrodes PageWriter TC20 989803175891, 12-Lead Patient Cable (IEC), Standard Length 989803175921, 12-Lead Patient Cable (AAMI), Long 989803175911, 12-Lead Patient Cable (IEC), Long 989803166031, Clear Tab/Snap Adapter 989803175901, 12-Lead Patient Cable (AAMI), Standard Length 989803129231, Alligator Clips, AMMI Holter 1810/ 2010 SW 989803151771, 15/16/18-Lead Upgrade Kit (AAMI), Long 989803151641, 12-Lead Complete Lead Set (IEC), Standard Length 989803164281, USB Patient Data Cable, Class B 989803151781, 15/16/18-Lead Upgrade Kit (IEC), Long 989803151661, 12-Lead Complete Lead Set (IEC), Long 989803151691, 12-Lead Chest Lead Set (AAMI/IEC), Long 989803151711, 12-Lead Limb Lead Set (AAMI/IEC), Standard Length 989803151671, 12-Lead Chest Lead Set (AAMI/IEC), Standard Length 989803151751, 15/16/18-Lead Upgrade Kit (AAMI), Standard Length 989803151651, 12-Lead Complete Lead Set (AAMI), Long 989803151761, 15/16/18-Lead Upgrade Kit (IEC), Standard Length 989803151631, 12-Lead Complete Lead Set (AAMI), Standard Length 989803151731, 12-Lead Limb Lead Set (AAMI/IEC), Long Cardiac Workstation 5000 CW 5000 (860439) CW 7000 (860441) Cardiac Workstation 7000 Wireless PIM Leadwire, 3mm needle AAMI (989803223951) Wireless PIM Leadwire, 4mm banana IEC (989803223961) Flex Adapter Nissha Adult Electrode Quadtrode CV MRI ECG Electrode Pad - 989803179041 40494E, Limb Clamp Electrode QUADTRODE MRI ECG PAD,25/BOX - 989803179031 Neonatal Quadtrode MRI ECG Electrode Pad - 989803179051 ePatch ECG Electrode Patch ECG Electrode MCOT Patch Patch electrode ePatch electrode 2-CH Patch Universal Patch BTP-1000P (Patch) Patch Philips ECG Comfort Patch Lead Wire Adapter Gel, ECG/EEG, Skin Prep, Tube, 3-Pack IntelliSpace ECG IntelliSpace ECG SW M1532A ECG Cable M1672A ECG Cable EEG Leadset - 989803180531 M1976A ECG Cable M1663A ECG Trunk Cable EEG Leadset - 989803180561 M1680A ECG Cable M1979A ECG Cable M1602A ECG Cable M1626A ECG Cable M1669A ECG Trunk Cable M1665A ECG Trunk Cable M1681A ECG Cable M1673A ECG Cable M1968A ECG Cable M1644A ECG Cable M1675A ECG Cable M1624A ECG Cable M1949A ECG Trunk Cable M1671A ECG Cable M1674A ECG Cable M1978A ECG Cable M1645A ECG Cable M1973A ECG Cable EEG Leadset - 989803180521 M1667A ECG Trunk Cable M1974A ECG Cable M1971A ECG Cable M1678A ECG Cable M2268A EEG Trunk Cable M1934A EEG Leadset CBL 5 Lead, Snap, Shld, AAMI, Chest, Rgd - 989803176171 M1668A ECG Trunk Cable EEG Leadset - 989803180541 CBL 5 Lead, Snap, Shld, AAMI, Limb, Rgd - 989803176161 M1533A ECG Cable CBL 5 Lead, Snap, Shld, IEC, Limb, Rgd - 989803176181 989803157501, DigiTrak XT Patient Cable, Long 989803157481, DigiTrak XT Patient Cable, short 989803157491, DigiTrak XT Patient Cable, Medium BTP-1000L-2-Lead Wire Adapter BTP-1000A-Hybrid Patch OMNI-TRAK 3000 SERIES

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility