BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V.

    Reg #: 3008729547 · FEI: 3008729547 · Expires 2026
    View on FDA
    Products
    55
    Proprietary Names
    273
    Establishment Types
    1
    Classifications
    55

    Registration Details

    Registration Name
    GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V.
    Registration Number
    3008729547
    FEI Number
    3008729547
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    CALLE VALLE DEL CEDRO 1551
    City
    JUAREZ Chihuahua
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K102426

    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
    Continuous Measurement Thermometer FLL
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Oximeter DQA
    System, Monitoring, Perinatal HGM
    Scale, Patient FRW
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    Warmer, Infant Radiant FMT
    Monitor, Airway Pressure (Includes Gauge And/Or Alarm) CAP
    Computer, Diagnostic, Pre-Programmed, Single-Function DXG
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Detector And Alarm, Arrhythmia DSI
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Spirometer, Monitoring (W/Wo Alarm) BZK
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Oximeter, Ear DPZ
    Probe, Thermodilution KRB
    Stimulator, Auditory, Evoked Response GWJ
    Computer, Oxygen-Uptake BZL
    Index-Generating Electroencephalograph Software OLW
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Electrocardiograph DPS
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Stimulator, Nerve, Peripheral, Electric KOI
    Reduced- Montage Standard Electroencephalograph OMC
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Computer, Blood-Pressure DSK
    Monitor, Breathing Frequency BZQ
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Alarm, Blood-Pressure DSJ
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Burst Suppression Detection Software For Electroencephalograph ORT
    Full-Montage Standard Electroencephalograph GWQ
    Computer, Diagnostic, Programmable DQK
    Monitor, St Segment With Alarm MLD
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Transmitters And Receivers, Electrocardiograph, Telephone DXH
    Recorder, Paper Chart DSF
    Incubator, Neonatal FMZ
    Oximeter, Tissue Saturation MUD
    Cerebral Oximeter QEM
    Display, Cathode-Ray Tube, Medical DXJ
    Ventilator, Emergency, Manual (Resuscitator) BTM
    Uterine Electromyographic Monitor OSP
    Blood Pressure Cuff DXQ
    Ventilator, Emergency, Powered (Resuscitator) BTL
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    System, Network And Communication, Physiological Monitors MSX
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Amplifier And Signal Conditioner, Transducer Signal DRQ
    Stand, Infusion FOX

    Proprietary Names

    CARESCAPE V100 VITAL SIGNS MONITOR ProCare V3 CARESCAPE V100 Corometrics 171 Coro 172 Corometrics 172 Corometrics 174 Coro 174 COROMETRICS 172 Monitor COROMETRICS 173 Monitor COROMETRICS 174 Monitor COROMETRICS 171 Monitor Coro 171 COROMETRICS 171 COROMETRICS 174 COROMETRICS 172 Patient Scale Giraffe Scale Giraffe In-Bed Scale GS1 Panda EU In-Bed Scale PS EU1 Giraffe EU In-Bed Scale GS EU1 Panda In-Bed Scale PS1 Panda Scale Venue Sprint 12L-RS E8C-RS 9L-RS 12S-RS Venue Fit C2-9-RS 8C-RS L10-22-RS L4-20t-RS 6S-RS 6Tc-RS 3Sc-RS L4-12t-RS L8-18i-RS M5Sc-RS ML6-15-RS C1-5-RS Giraffe Warmer Panda Freestanding Warmer Panda Wall Mount Warmer Panda Ires Warmer Disposable Infant Skin Temperature Probe Giraffe Panda Disposable Infant Skin Temperature Probe Panda Warmer Panda iRes Warmer CARESCAPE MONITOR B450 CARESCAPE MONITOR B450-LI CARESCAPE Monitor B450 BEDRAIL HOOK: BEDRAIL HOOK UNIT CARESCAPE B450 BRH MAC 3500 MAC 5500 HD MAC 5500 HD ECG ANALYSIS SYSTEM CAM HD CAM 14 B1X5-REC, Recorder Giraffe OmniBed Carestation Giraffe OmniBed Carestation CS1 E-musb CARESCAPE B650 CARESCAPE RAD CSCS CSCS v2 CARESCAPE Central Station CARESCAPE Central Station v2 CARESCAPE Central Station v3 CSCS v3 Vscan Air CL Vscan Air Giraffe OmniBed + Shuttle Giraffe Omnibed Giraffe Shuttle C3-10-D BE9CS-RS P6D M5sc-RS L3-12-RS C1-6-D LOGIQ P8 E8CS-RS IC9-RS RAB2-6-RS L6-12-RS RIC5-9A-RS LOGIQ P10 LOGIQ P9 P2D StAR Giraffe Stand-alone Infant Resuscitation System (Bag and Mask) Giraffe and Panda Bag and Mask Resuscitation System Giraffe Stand-alone Infant Resuscitation System Venue L12n-RS Giraffe Omnibed Carestation CS1 Novii Novii Wireless Patch System Novii Interface Novii Pod MAC VU360 Resting ECG Analysis System CAM Connect 14, CC14 CAM Connect 14 with Barcode, CC14 w/BC CAM Connect 14 w/ BC 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 Vscan Air SL 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) 4C-RS LOGIQ P7 CARESCAPE B450 Portrait VSM Vital Signs Monitor Portrait VSM Portrait™ VSM CARESCAPE Canvas Smart Display F2 Frame (F2-01) CARESCAPE Canvas D19 CARESCAPE Canvas 1000 Radial-Cuf Non-invasive Blood Pressure Cuff B125M Patient Monitor B1X5-F2, Second Frame B155M Patient Monitor B105P Patient Monitor Monitor B105M Monitor B125M B105M Patient Monitor VSP 4 Upgrade Software Monitor B155M Monitor B125P Monitor B105P B125P Patient Monitor Giraffe Stand-alone Infant Resuscitation System (T-piece) Giraffe Stand-alone Infant Resuscitation System (T-piece, and Bag and Mask) MAC 7 Resting ECG Analysis System Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) Portrait™ Central Viewer Application (Portrait CVA01) Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SE01) Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01) Portrait™ Sensor Battery (Portrait SBT01) Portrait™ Core Services (Portrait CSS01) Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-W01) Portrait™ Bedside Charger (Portrait BCH01) Portrait™ Mobile Patient Monitor (Portrait HUB01) Portrait™ Clinical Alarming Unit (Portrait CAU01) Portrait™ Mobile Patient Monitor Pouch (Portrait MMP01) Portrait™ RR Electrode Patch (Portrait RRP01) Portrait™ Wearable Respiration Rate Sensor (Portrait RR P-RR01) Novii+ Wireless Patch System Novii+ Interface Novii+ Pod Venue Go Coro 173 Corometrics 173 PSM MODULE BUS ADAPTER SHORT PSM POLE MOUNT LONG PSM POLE MOUNT DATEX-OHMEDA S/5 E-PSM(P) MODULE TruSignal SpO2 Finger Sensor, GE connector (TS-F4-GE) TruSignal SpO2 Ear Sensor, GE connector (TS-E4-GE) Corometrics 256CX Corometrics 250CX Corometrics 259CX Coro 250CX F5 Frame F7 Frame CARESCAPE MONITOR B850 CARESCAPE D19KT CARESCAPE MONITOR B850-LI USB Remote Control LOGIQ e CARESCAPE B850 F7-01 Frame F5-01 Frame CARESCAPE D19KT VER01 CARESCAPE ONE CARESCAPE DOCK FO CARESCAPE PRES CARESCAPE TEMP CARESCAPE SPO2 CARESCAPE ECG Venue Trident MAC 7 - Resting ECG Analysis System Giraffe Incubator + Shuttle Giraffe Incubator Giraffe Incubator Carestation CS1 Giraffe Incubator Carestation APEXPRO RECEIVER SUBSYSTEM CARESCAPE TELEMETRY SYSTEM APEXPRO CH NONIN XPOD OXIMETER APEXPRO QUAD RECEIVER MODULE ApexPro Telemetry System CARESCAPE Telemetry Server CARESCAPE T4 Transmitter ApexPro CH Transmitter CARESCAPE Telemetry T4 Transmitter CARESCAPE T14 Transmitter ApexPro FH Transceiver ApexPro 400 MHz Receiver ApexPro 600 MHz Receiver CARESCAPE Telemetry Server V4 CARESCAPE TELEMETRY SERVER V4 UPGRADE Solar 8000i Transport Pro with Patient Data Mo Patient Data Module Defib Sync Cables Panda iRes Portrait Core Services CSSXB Portrait RR P-RR01 Portrait BCH01 Portrait MMP01 Portrait AAB01 Portrait SpO2 P-W01 Portrait SpO2 P-SP01 Portrait SBT01 Portrait SpO2 P-SE01 Portrait SpO2 P-SA01 Portrait RRP01 Portrait CVAXB Portrait HUBXB Portrait HSWXB Portrait CAU01 DURA-CUF CLASSIC-CUF SENSA-CUF SOFT-CUF NIBP Hoses NIBP connectors NIBP adaptors (Dinaclick, Bayonet, Neo-Snap) CARESCAPE MONITOR B650 CARESCAPE Monitor B650-LI CARDIOSOFT WEB CardioSoft V6.71. Cardiac Testing System CS V6.71 Cardiac Testing System CARDIOSOFT RESTING ECG CS V6.6. Cardiac Testing System CASE CASE V6.6. Cardiac Testing System CARDIOSOFT EKG VIEWER CASE V6.71. Cardiac Testing System CARDIOSOFT CLIENT Cardiosoft V6.72 CASE V6.7 CS V6.71 CARDIOSOFT EXERCISE STRESS TEST CardioSoft V6.73 CS V6.6 Cardiac Testing System CARDIOSOFT SERVER CardioSoft V6.71 Cardiac Testing System CASE V6.6 Cardiac Testing System CASE V6.71 Cardiac Testing System CASE V6.73 IV Pole ROTATING IV POLE Rotating IV1 IV POLE ASSY 12 IN 12 Inch IV1 IV POLE ASSY 24 IN 24 Inch IV1 LULLABY IV POLE IV1 MAC 2000 E7C8L-RS LOGIQ P10 R4 to R4.5 UPG LOGIQ P9 R4 to R4.5 UPG LOGIQ P8 R4 to R4.5 UPG CASE V7 Cardiac Testing System CardioSoft V7 Cardiac Testing System

    Establishment Types

    Manufacture Medical Device