BEUDAMED
    FDA Registration Active 🇨🇳 China

    GE MEDICAL SYSTEMS (CHINA) CO., LTD.

    Reg #: 9710602 · FEI: 3003513129 · Expires 2026
    View on FDA
    Products
    56
    Proprietary Names
    361
    Establishment Types
    3
    Classifications
    56

    Registration Details

    Registration Name
    GE MEDICAL SYSTEMS (CHINA) CO., LTD.
    Registration Number
    9710602
    FEI Number
    3003513129
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    NO. 19 CHANGJIANG ROAD, NATIONAL HI-TECH DEV. ZONE
    City
    WUXI Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K051367
    PMA Number
    P110006

    Owner / Operator

    Firm Name
    GE HealthCare Technologies Inc.
    Operator Number
    9912004
    Address
    3000 N. Grandview Blvd
    City
    Waukesha
    State
    WI
    Postal Code
    53188
    Country
    US

    US Agent

    Business Name
    GE HealthCare Technologies, Inc
    Contact Name
    Tracey Holevas
    Address
    3000 N. Grandview BLVD
    City
    Waukesha
    State
    WI
    ZIP
    53188
    Country
    US
    Email
    [email protected]
    Phone
    262 3092157

    Products

    Device Name Product Code
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX
    Catheter, Ultrasound, Intravascular OBJ
    Stimulator, Auditory, Evoked Response GWJ
    Burst Suppression Detection Software For Electroencephalograph ORT
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Reduced- Montage Standard Electroencephalograph OMC
    Monitor, St Segment With Alarm MLD
    Gas-Machine, Anesthesia BSZ
    Stimulator, Nerve, Peripheral, Electric KOI
    Cable, Electrode IKD
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Computer, Diagnostic, Programmable DQK
    Full-Montage Standard Electroencephalograph GWQ
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Electrocardiograph DPS
    Index-Generating Electroencephalograph Software OLW
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Oximeter DQA
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Monitor, Breathing Frequency BZQ
    Detector And Alarm, Arrhythmia DSI
    Cerebral Oximeter QEM
    Alarm, Blood-Pressure DSJ
    Computer, Oxygen-Uptake BZL
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Computer, Blood-Pressure DSK
    Oximeter, Ear DPZ
    Spirometer, Monitoring (W/Wo Alarm) BZK
    Probe, Thermodilution KRB
    Oximeter, Tissue Saturation MUD
    Monitor, Airway Pressure (Includes Gauge And/Or Alarm) CAP
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Continuous Measurement Thermometer FLL
    Automated Radiological Image Processing Software QIH
    Ventilator, Continuous, Facility Use CBK
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Transmitters And Receivers, Electrocardiograph, Telephone DXH
    Incubator, Neonatal FMZ
    Warmer, Infant Radiant FMT
    Catheter, Intravascular, Diagnostic DQO
    Absorber, Carbon-Dioxide BSF
    Bone Sonometer MUA
    System, Image Processing, Radiological LLZ
    Electrode, Cutaneous GXY
    Recorder, Paper Chart DSF
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    System, Monitoring, Perinatal HGM
    Automated Breast Ultrasound PAA

    Proprietary Names

    Nellcor OxiMax, 3m/10ft 2021406-002 SpO2 Interconnect cable 2021406-001 SpO2 Interconnect cable Nellcor OxiMax, 1.2m/3.9ft ML6-15-D IC5-9-D L2-9VN-D L2-9-D C1-6VN-D L3-12-D C2-9VN-D 6S-D L8-18i-D LOGIQ E10 RAB6-D 6Tc-RS RIC5-9-D ML4-20-D M5Sc-D ML4-20VN-D C3-10-D P6D BE9CS-D C2-9-D P2D C1-6-D iC5-9-D 6Vc-D 8C 12S-D 4Vc-D Vivid E80 10T-D 4V-D 11L-D 9T-RS Vivid E90 Vivid E95 9T 9L-D 4D ICE catheter 6VT-D 12L-RS Venue 9L-RS C1-5-RS E8C-RS 8C-RS L8-18i-RS 3Sc-RS L12n-RS L4-12t-RS 6S-RS L4-20t-RS Venue Fit ML6-15-RS L10-22-RS 12S-RS LK760-RS L6-12-RS 4C-RS Versana Balance RAB2-6-RS E8Cs-RS Datex-Ohmeda S/5 EEG Module E-EEG Datex-Ohmeda S/5 EEG Headbox AEP Ear Tips for Earphone Set (8001233) EEG Lead set 3 (898052) EEG Lead set 1 (898050) LOGIQ e M5Sc-RS C2-9-RS Venue Sprint LOGIQ F8 Expert LOGIQ F6 BE9CS-RS LOGIQ F8 Vivid T8 RIC10-D RSP6-16-D RM6C RIC12-D RM7C Voluson Expert 22 Voluson Expert 20 RIC6-12-D Voluson Expert 18 eM6C G3 Carestation 750 Carestation 750c Carestation 750/750c Carestation 750 A1 Carestation 750c A1 L4-20t-D NEUROMUSCULAR TRANSMISSION MODULE, E-NMT DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT NMT Regional Block Adapter 0.5m/1.5ft NMT MechanoSensor 0.3m/1ft NMT ElectroSensor 0.3m/1ft NMT Pediatric MechanoSensor 0.3m/1ft NMT Sensor Cable 3.3m/11ft NMT Electrodes, Solid Gel, Ag/AgCl, 30/pkg Vivid iq Vivid iq v206 to v208 SW only UPG Vivid iq v206 to v208 HW+SW UPG Voluson E6 Voluson E8 C1-5-D eM6C G2 C4-8-D Voluson E10 RAB2-5-D RNA5-9-D eM6C IC9-D ECG Trunk Cables and Leadwires Trunk Cables (Cardiac Output Cables, Invasive Blood Pressure Cables, Temperature Cables) ECG Adapter Cable NOVII INTERFACE CABLE - GE FECG MECG Cable FECG Cable CLAB ECG Trunk Cable 12-lead AHA 10ft CLAB ECG Trunk Cable 12-lead IEC 10ft NOVII INTERFACE CABLE - GE MECG Novii Cables (NOVII INTERFACE CABLE - GE FECG; NOVII INTERFACE CABLE - GE MECG; NOVII INTERFACE CABLE - GE UA) 4 Leadwire Expansion Cable, grabber, IEC, 74 cm/29 in. NOVII INTERFACE CABLE - GE UA 4 Leadwire Expansion Cable, snap, IEC, 74 cm/29 in. 4 Leadwire Expansion Cable, grabber, IEC, 130 cm/51 in. Cable assembly ECG 3 lead neo IEC long, 3.6 m Cable assembly ECG 3 lead neo AHA short, 1.8 m Cable assembly ECG 3 lead neo AHA long, 3.6 m 4 Leadwire Expansion Cable, snap, IEC, 130 cm/51 in. Cable assembly ECG 3 lead neo IEC short, 1.8 m 4 Leadwire Expansion Cable, snap, AHA, 130 cm/51 in. 4 Leadwire Expansion Cable, grabber, AHA, 74 cm/29 in. 4 Leadwire Expansion Cable, snap, AHA, 74 cm/29 in. 4 Leadwire Expansion Cable, grabber, AHA, 130 cm/51 in. Venue Go RAB4-8-RS Voluson i Voluson e RAB2-5-RS RIC5-9W-RS RNA5-9-RS LOGIQ V2 LOGIQ V1 CARESCAPE Canvas Smart Display F2 Frame (F2-01) CARESCAPE Canvas D19 CARESCAPE Canvas 1000 Vivid Pioneer 9VT-D 6Sc-D 10-D LOGIQ S8 Venue Trident LOGIQ E10s LOGIQ Fortis LOGIQ E10s R2 to R3 UPG Voluson S10 Voluson S8t Voluson S10 Expert Voluson S8 IC9B-RS IC9-RS RIC5-9A-RS Voluson S6 ML6-15 BE9CS LOGIQ S7 Expert RAB4-8-D RAB6-RS Voluson SWIFT Voluson SWIFT+ Voluson S6 BT16 Voluson S series Voluson S8 BT16 Voluson S series BT16 Voluson S10 BT16 B1X5-F2, Second Frame B125M Patient Monitor B105P Patient Monitor Monitor B105M Monitor B125M Monitor B155M B125P Patient Monitor Monitor B125P B105M Patient Monitor Monitor B105P B155M Patient Monitor LOGIQ E10s R2R3 to R4 SW Upgrade W LOGIQ Fortis R3 to R4 SW Upgrade W LOGIQ E10s R2R3 to R4 SW Upgrade LOGIQ Fortis R3 to R4 HW Upgrade LOGIQ Fortis R3 to R4 HW Upgrade W LOGIQ E10s R2R3 to R4 HW Upgrade LOGIQ Fortis R3 to R4 SW Upgrade LOGIQ E10s R2R3 to R4 HW Upgrade W Voluson P8 Voluson P6 LOGIQ S20 LOGIQ S20 Express LOGIQ Vita Power LOGIQ Vita Express LOGIQ S20 Plus LOGIQ S20 Pro LOGIQ Vita Plus LOGIQ S20 Power LOGIQ Vita LOGIQ Vita Pro Versana Essential Carestation 650c Carestation 620 Carestation 650 A1 Carestation 620 A1 Carestation 620/650/650c Carestation 650 Carestation 650c A1 CARESCAPE R860 Ventilator R860 CARESCAPE R860 Versana Premier E7C8L-RS L3-12-RS Vivid T9 MAC 7 Resting ECG Analysis System Giraffe OmniBed Carestation Giraffe OmniBed Carestation CS1 Giraffe Panda Disposable Infant Skin Temperature Probe Disposable Infant Skin Temperature Probe CONTINUOUS CARDIAC OUTPUT MODULE, E-PiCCO-00 PiCCO Injectate Sensor Cable (M1182448) PiCCO Continuous Cardiac Output Cable (M1154585) LOGIQ P9 M5sc-RS LOGIQ P10 E8CS-RS LOGIQ P8 LOGIQ P10 R4 to R4.5 UPG LOGIQ P9 R4 to R4.5 UPG LOGIQ P8 R4 to R4.5 UPG Multi-Absorber canister reusable Absorber canister assembly ABS Reusable Absorbent Canister Reusable Absorber Canister Reusable Absorbent Canister Reusable CO2 Absorber Canister Multi Absorber Canister CBS Reusable Absorbent Canister reusable Vivid S70N Vivid S60N RAB7-D VSP 4 Upgrade Software Giraffe Incubator Carestation CS1 Giraffe Incubator Carestation Versana Active Giraffe Warmer Panda Freestanding Warmer Panda Wall Mount Warmer Panda Ires Warmer Panda Warmer Vscan Extend G3S, deep scanning transducer G8L, shallow scanning transducer Vscan Extend dual probe dual probe Voluson E series BT15 Voluson E series Achilles OsteoReportN 9L t739 ERB 11L 12L 4C E8C 10L E8CS GE ENTROPY SENSOR (REFM1038681) GE ENTROPY CABLE (REF M1050784) LOGIQ E9 M6C-D 3CRF LOGIQ E9 XDClear 2 S4-10-D Voluson Signature 20 Voluson Signature 18 G3S, Deep Scanning Transducer G8L, Shallow Scanning Transducer TRAM 2001 Module 2006644-001 SpO2 Interconnect cable Nellcor OxiSmart, 2.9m/9.5ft 5CS 3S 3.5C 7S LOGIQ P5 4D3C-L Vivid T8 T9 v206 to v208 SW only UPG MAC 5 A4 MAC 5 A4 Resting ECG Analysis System MAC 5 A5 MAC 5 Lite Resting ECG Analysis System MAC 5 Lite MAC 5 A5 Resting ECG Analysis System LOGIQ P7 E8Cs-RS (only for Vivid T9) C1-5-RS (only for Vivid T9) 11M3 LOGIQ Totus 6Tc Vivid S70 Vivid S60 eM6CG2 Voluson E series BT16 Voluson E6 BT16 Voluson E10 BT16 Voluson E8 BT16 Vivid S70N Dimension Venue 50 L8-18i-SC E8CS-SC 3S-SC 4C-SC L12n-SC 12L-SC Achilles EXPII B1X5-REC, Recorder LOGIQ e NextGen NextGen LOGIQ e LOGIQ V5 LOGIQ V5 Expert LOGIQ V3 LOGIQ F Versana Premier Lotus TruSignal SpO2 Finger Sensor (TS-F-D) TruSignal SpO2 Sensitive Skin (TS-SE-3) TruSignal SpO2 Ear Sensor (TS-E-D) TruSignal SpO2 Interconnect Cable with GE connector (TS-G3) TruSignal SpO2 attachment accessories (TS-HB-3, TS-RWL-24, TS-RTW-100, TS-SND-3, TS-RWS-24, TS-RWM-24) Voluson Performance 18 Voluson Performance 16 Portrait VSM Vital Signs Monitor Portrait VSM Portrait™ VSM 2025350-001 SpO2 Interconnect cable, Nellcor OxiMax, 3m/10ft, Corometrics only Vivid T8 T9 v204 v205 to v206 UPG SW only Vivid T8 T9 v204 v205 to v206 UPG L6-24-D Invenia ABUS Viewer MAC 7 - Resting ECG Analysis System Invenia ABUS Workstation Invenia ABUS Invenia ABUS Scan Station Invenia ABUS Review Software ABUS Single-Use Stabilization Membrane - non Sterile Invenia ABUS 2 Invenia ABUS Prime Invenia ABUS Premium

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)