BEUDAMED
    FDA Registration Active 🇮🇳 India

    WIPRO GE HEALTHCARE PRIVATE Ltd.

    Reg #: 3007734888 · FEI: 3007734888 · Expires 2026
    View on FDA
    Products
    28
    Proprietary Names
    139
    Establishment Types
    1
    Classifications
    28

    Registration Details

    Registration Name
    WIPRO GE HEALTHCARE PRIVATE Ltd.
    Registration Number
    3007734888
    FEI Number
    3007734888
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    122 (Part 1), JOHN F. WELCH TECHNOLOGY CENTRE, ODYSSEY AND GALILEO, EXPORT PROMOTIONAL INDUSTRIAL PARK, WHITEFIELD
    City
    BANGALORE Karnataka
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K993751

    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
    System, Monitoring, Perinatal HGM
    System, X-Ray, Mobile IZL
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    Unit, Neonatal Phototherapy LBI
    Uterine Electromyographic Monitor OSP
    Incubator, Neonatal FMZ
    Warmer, Infant Radiant FMT
    Stand, Infusion FOX
    Electrocardiograph DPS
    Instrument, Quality-Assurance, Radiologic LHO
    Ventilator, Emergency, Powered (Resuscitator) BTL
    Automated Radiological Image Processing Software QIH
    Radiological Computer-Assisted Prioritization Software For Lesions QFM
    Computer, Diagnostic, Programmable DQK
    Monitor, Heart Rate, Fetal, Ultrasonic HEL
    Monitor, Uterine Contraction, External (For Use In Clinic) HFM
    Scale, Patient FRW
    Binder, Abdominal FSD
    Ventilator, Emergency, Manual (Resuscitator) BTM
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Transmitters And Receivers, Electrocardiograph, Telephone DXH
    Electrode, Electrocardiograph DRX
    System, Image Processing, Radiological LLZ
    System, Nuclear Magnetic Resonance Imaging LNH
    Mattress, Flotation Therapy, Non-Powered IKY
    Radiological Computer Assisted Detection/Diagnosis Software For Fracture QBS
    Display, Cathode-Ray Tube, Medical DXJ
    Detector And Alarm, Arrhythmia DSI

    Proprietary Names

    Coro 173 Corometrics 171 Corometrics 174 Corometrics 173 Corometrics 172 Optima XR240amx BiliSoft 2 Phototherapy System BiliSoft LED Phototherapy System BiliSoft BiliSoft Phototherapy System Novii Novii Wireless Patch System Novii Interface Novii Pod Giraffe OmniBed + Shuttle Giraffe Omnibed Giraffe Shuttle 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 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 600 Resting ECG Analysis System MAC 600 IQST assembly Quality Care Suite 2 Mini Telemetry System Giraffe Stand-alone Infant Resuscitation System (T-piece) StAR Giraffe Stand-alone Infant Resuscitation System (T-piece, and Bag and Mask) Panda iRes Warmer Giraffe Stand-alone Infant Resuscitation System Giraffe Incubator Carestation CS1 Giraffe Incubator Carestation Critical Care Suite with Endotracheal Tube Positioning AI Algorithm Critical Care Suite 2 Optima XR220amx Optima XR200amx Critical Care Suite Coro 172 Coro 174 COROMETRICS 172 Monitor COROMETRICS 173 Monitor COROMETRICS 174 Monitor COROMETRICS 171 Monitor Coro 171 COROMETRICS 171 COROMETRICS 174 COROMETRICS 172 CASE V7 Cardiac Testing System CardioSoft V7 Cardiac Testing System Lullaby LED PT Lullaby LED Phototherapy System AMX Navigate AMX Navigate UPGRADE COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER 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 Transducer Belt Giraffe Omnibed Carestation CS1 Lullaby Warmer Giraffe Stand-alone Infant Resuscitation System (Bag and Mask) Giraffe and Panda Bag and Mask Resuscitation System Giraffe Incubator + Shuttle Giraffe Incubator Mural Clinical Viewer MAC 3500 MAC 5500 HD MAC 5500 HD ECG ANALYSIS SYSTEM CAM HD CAM 14 CareIntellect Perinatal Mural Perinatal Surveillance Novii Patch 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 Blue Spot PT Giraffe Blue Spot PT Lite Blue Spot PT Lite Panda iRes CRC Customer Remote Console Remote Console Digital Expert Access Novii+ Wireless Patch System Novii+ Interface Novii+ Pod Giraffe OmniBed Carestation Giraffe OmniBed Carestation CS1 Digital Expert Access with Remote Scanning Giraffe Warmer (Uninterruptible Power Supply) Panda Warmer (Uninterruptible Power Supply) Pressure Diffusing Mattress GIRAFFE PRESSURE DIFFUSING MATTRESS Corometrics 256CX Corometrics 250CX Corometrics 259CX Coro 250CX Critical Care Suite 2.1 Collimator Collimator X-Ray Brivo XR285amx CSCS CSCS v2 CARESCAPE Central Station CARESCAPE Central Station v2 CARESCAPE Central Station v3 CSCS v3

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility