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    FDA Registration Active 🇮🇳 India

    WIPRO GE MEDICAL DEVICE MANUFACTURING PRIVATE LIMITED

    Reg #: 3032109181 · FEI: 3032109181 · Expires 2026
    View on FDA
    Products
    38
    Proprietary Names
    250
    Establishment Types
    1
    Classifications
    38

    Registration Details

    Registration Name
    WIPRO GE MEDICAL DEVICE MANUFACTURING PRIVATE LIMITED
    Registration Number
    3032109181
    FEI Number
    3032109181
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 4 Kadugodi Industrial Area, Sadarmangala, Whitefield
    City
    Bangalore Karnataka
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K192956

    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, X-Ray, Tomography, Computed JAK
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transmitters And Receivers, Electrocardiograph, Telephone DXH
    Electrocardiograph DPS
    Computer, Diagnostic, Programmable DQK
    System, Nuclear Magnetic Resonance Spectroscopic LNI
    System, Nuclear Magnetic Resonance Imaging LNH
    Automated Radiological Image Processing Software QIH
    Alarm, Blood-Pressure DSJ
    Oximeter, Ear DPZ
    Oximeter DQA
    Reduced- Montage Standard Electroencephalograph OMC
    Index-Generating Electroencephalograph Software OLW
    Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) NHO
    Probe, Thermodilution KRB
    Burst Suppression Detection Software For Electroencephalograph ORT
    System, Measurement, Blood-Pressure, Non-Invasive DXN
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) CBQ
    Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) CBS
    Full-Montage Standard Electroencephalograph GWQ
    Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) DRT
    Continuous Measurement Thermometer FLL
    Computer, Blood-Pressure DSK
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Detector And Alarm, Arrhythmia DSI
    Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) NHQ
    Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) NHP
    Monitor, St Segment With Alarm MLD
    Monitor, Breathing Frequency BZQ
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Stimulator, Nerve, Peripheral, Electric KOI
    Table, Radiographic, Non-Tilting, Powered IZZ
    Catheter, Ultrasound, Intravascular OBJ

    Proprietary Names

    Auto Positioning L8-18i-RS C1-5-RS L4-12t-RS 12L-RS L10-22-RS Venue Go E8C-RS 9L-RS 8C-RS 6S-RS 3Sc-RS 12S-RS ML6-15-RS L4-20t-RS 6Tc-RS P6D 8C Vivid E95 11L-D C1-6-D L8-18i-D Vivid E80 9T C3-10-D 9T-RS C2-9-D 4V-D Vivid E90 M5Sc-D 6S-D P2D 9L-D iC5-9-D 12S-D 6VT-D 10T-D ML6-15-D 6Vc-D 4Vc-D ML6-15 IC5-9-D BE9CS BE9CS-D C1-5-D L3-12-D LOGIQ S7 Expert RIC5-9-D RAB4-8-D C2-9-RS M5Sc-RS Venue L12n-RS Venue Sprint Venue Fit LOGIQ E10s R2R3 to R4 SW Upgrade W LOGIQ Fortis R3 to R4 SW Upgrade W C2-9VN-D L4-20t-D RAB6-D LOGIQ Fortis ML4-20VN-D L2-9VN-D LOGIQ E10s R2R3 to R4 SW Upgrade LOGIQ E10s C1-6VN-D L2-9-D ML4-20-D 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 E8Cs-RS Vivid iq 4C-RS LK760-RS L6-12-RS Versana Balance RAB2-6-RS 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 SIGNA Prime Elite Optima CT680 Expert Revolution Maxima Revolution Ace Console Generation Upgrade Versana Premier RIC5-9A-RS Vivid T8 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 LOGIQ e E7C8L-RS BE9CS-RS Voluson P6 Voluson P8 IC9-RS Voluson E6 Voluson E8 eM6C G2 RM7C C4-8-D Voluson E10 RSP6-16-D RM6C RAB2-5-D eM6C G3 RNA5-9-D RIC6-12-D eM6C IC9-D L3-12-RS Voluson E series BT15 Voluson E series 9VT-D Versana Active Versana Essential E8CS-RS LOGIQ P9 LOGIQ P7 RAB4-8-RS Voluson i Voluson e RAB2-5-RS RIC5-9W-RS RNA5-9-RS LOGIQ E10 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 Vivid T9 Vivid T8 T9 v206 to v208 SW only UPG IC9B-RS RAB6-RS Voluson SWIFT Voluson SWIFT+ LOGIQ F Versana Premier Lotus NG2000 ELITE HEAVY TABLE GT1700V(GT1700V N9 ED3, GT1700V) VT1700V(GT1700V N9 ED3) GT1700V (GT1700V N9 ED3, GT1700V) VT1700 (GT1700 N9 ED3) VT2000X(GT2000x) Lite (LITE TABLE N9 ED3, Lite Table) NG 2000 Table NM/CT Patient Table VT2000 (GT2000 N9 ED3) Kunlun Table NG2000V table G3 RAD Elevation Table Standard table NG1700 Patient Table Table (Model: GCTBL-C4) Table (Model: GCTBL-C33) NG LITE 1700 (NG1700 ELITE STANDARD TABLE) NG2000SV Table NG LITE 2000 (NG2000 ELITE HEAVY TABLE) NG2000SV TABLE NG1700 ELITE STANDARD TABLE Radiographic Table (Model: VFTBL-1) NG1700SV Table Table (Model: GCTBL-C3333) NG1700SV TABLE Vivid iq v206 to v208 SW only UPG Vivid iq v206 to v208 HW+SW UPG Vivid S70N Vivid S60N Vivid S70N Dimension Voluson Performance 18 Voluson Performance 16 eM6CG2 Voluson E series BT16 Voluson E6 BT16 Voluson E10 BT16 Voluson E8 BT16 Voluson S6 BT16 Voluson S10 Voluson S series Voluson S8 BT16 Voluson S8 Voluson S6 Voluson S series BT16 Voluson S10 BT16 LOGIQ E9 M6C-D 3CRF LOGIQ E9 XDClear 2 S4-10-D LOGIQ Totus L6-24-D Revolution ACT RIC10-D RIC12-D Voluson Expert 22 Voluson Expert 20 Voluson Expert 18 LOGIQ V5 LOGIQ V5 Expert LOGIQ V3 LOGIQ F8 Expert LOGIQ F6 LOGIQ F8 RAB7-D Vivid Pioneer 6Sc-D 10-D LOGIQ V2 LOGIQ V1 M5sc-RS LOGIQ P8 LOGIQ P10 LOGIQ P10 R4 to R4.5 UPG LOGIQ P9 R4 to R4.5 UPG LOGIQ P8 R4 to R4.5 UPG LOGIQ E10s R2 to R3 UPG Vivid T8 T9 v204 v205 to v206 UPG SW only Vivid T8 T9 v204 v205 to v206 UPG Venue Trident E8Cs-RS (only for Vivid T9) C1-5-RS (only for Vivid T9) 4D ICE catheter LOGIQ S8 Voluson S8t Voluson S10 Expert LOGIQ e NextGen NextGen LOGIQ e Voluson Signature 20 Voluson Signature 18

    Establishment Types

    Manufacture Medical Device