BEUDAMED
    FDA Registration Active 🇮🇳 India

    Wipro GE Healthcare Private Ltd.

    Reg #: 9617277 · FEI: 3003190524 · Expires 2026
    View on FDA
    Products
    17
    Proprietary Names
    248
    Establishment Types
    1
    Classifications
    17

    Registration Details

    Registration Name
    Wipro GE Healthcare Private Ltd.
    Registration Number
    9617277
    FEI Number
    3003190524
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4, Kadugodi Industrial Area
    City
    Bangalore Karnataka
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K160184

    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
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Warmer, Infant Radiant FMT
    Binder, Abdominal FSD
    Automated Radiological Image Processing Software QIH
    System, Monitoring, Perinatal HGM
    Transmitters And Receivers, Electrocardiograph, Telephone DXH
    Computer, Diagnostic, Programmable DQK
    Electrocardiograph DPS
    Monitor, Heart Rate, Fetal, Ultrasonic HEL
    Monitor, Uterine Contraction, External (For Use In Clinic) HFM
    Stand, Infusion FOX
    Catheter, Ultrasound, Intravascular OBJ
    Unit, Neonatal Phototherapy LBI
    System, Image Processing, Radiological LLZ
    System, Nuclear Magnetic Resonance Imaging LNH

    Proprietary Names

    8C-RS Voluson S6 BT16 RAB6-RS E8C-RS IC9-RS Voluson S10 12L-RS Voluson S series Voluson S8 BT16 Voluson S8 3Sc-RS Voluson S6 9L-RS 12S-RS Voluson S series BT16 Voluson S10 BT16 RIC5-9A-RS ML6-15-RS C1-5-RS 4C-RS L8-18i-RS L12n-RS L4-20t-RS Venue 6S-RS L4-12t-RS 6Tc-RS L10-22-RS Venue Trident Versana Premier L6-12-RS E8Cs-RS LOGIQ F L3-12-RS E7C8L-RS BE9CS-RS RAB2-6-RS Versana Premier Lotus LK760-RS P2D 9L-D 11L-D 4Vc-D Vivid S70N C3-10-D Vivid S60N ML6-15-D C1-5-D 6S-D C1-6-D 12S-D 9T-RS 6VT-D Vivid S70N Dimension P6D L8-18i-D IC5-9-D C2-9-D M5Sc-D 9T Vivid E80 8C 4V-D 10T-D Vivid E90 Vivid E95 iC5-9-D Vivid Pioneer 9VT-D 6Sc-D 10-D 6Vc-D Lullaby Warmer Versana Active Transducer Belt 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 Venue Fit Voluson Performance 18 IC9B-RS Voluson Performance 16 Venue Go M5Sc-RS C2-9-RS Coro 173 Corometrics 171 Corometrics 174 Corometrics 173 Corometrics 172 L4-20t-D BE9CS-D RAB6-D C2-9VN-D C1-6VN-D LOGIQ Fortis L3-12-D RIC5-9-D L2-9-D L2-9VN-D Voluson Expert 18 RM7C RM6C RIC6-12-D RIC10-D RAB7-D Voluson Expert 22 RIC12-D RSP6-16-D Voluson Expert 20 eM6C G3 IC9-D eM6C G2 eM6C Voluson E10 RAB2-5-D Voluson E6 Voluson E8 RNA5-9-D LOGIQ e NextGen LOGIQ e NextGen LOGIQ e LOGIQ P7 Versana Essential Vivid iq Versana Balance Vivid T8 T9 v204 v205 to v206 UPG SW only Vivid T8 T9 v204 v205 to v206 UPG Vivid T9 Vivid T8 LOGIQ S8 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 Mini Telemetry System Vivid T8 T9 v206 to v208 SW only UPG MAC 3500 MAC 5500 HD MAC 5500 HD ECG ANALYSIS SYSTEM CAM HD CAM 14 Voluson SWIFT+ Voluson SWIFT LOGIQ E10 ML4-20-D ML4-20VN-D Vivid iq v206 to v208 SW only UPG Vivid iq v206 to v208 HW+SW UPG 5CS 3S 3.5C 7S LOGIQ P5 10L 12L 4D3C-L 12L-SC 4C-SC 3S-SC L8-18i-SC Venue 50 E8CS-SC LOGIQ E10s C4-8-D LOGIQ V2 LOGIQ V1 Voluson S8t Voluson S10 Expert LOGIQ F8 Expert LOGIQ F6 LOGIQ F8 COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER 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 Coro 172 Coro 174 COROMETRICS 172 Monitor COROMETRICS 173 Monitor COROMETRICS 174 Monitor COROMETRICS 171 Monitor Coro 171 COROMETRICS 171 COROMETRICS 174 COROMETRICS 172 Voluson Signature 20 Voluson Signature 18 ML6-15 BE9CS LOGIQ S7 Expert RAB4-8-D LOGIQ E9 M6C-D 3CRF LOGIQ E9 XDClear 2 S4-10-D 4D ICE catheter Lullaby LED PT Lullaby LED Phototherapy System LOGIQ Totus MAC 600 Resting ECG Analysis System MAC 600 Venue Sprint CRC Customer Remote Console Remote Console Digital Expert Access Corometrics 256CX Corometrics 250CX Corometrics 259CX Coro 250CX L12n-SC 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 LOGIQ E10s R2 to R3 UPG E8Cs-RS (only for Vivid T9) C1-5-RS (only for Vivid T9) RAB4-8-RS Voluson i Voluson e RAB2-5-RS RIC5-9W-RS RNA5-9-RS Digital Expert Access with Remote Scanning 6Tc Vivid S70 Vivid S60

    Establishment Types

    Manufacture Medical Device