FDA Registration Active 🇮🇳 India

WIPRO GE HEALTHCARE PRIVATE LTD

Reg #: 9613936 · FEI: 1000571342 · Expires 2026
Products
5
Proprietary Names
140
Establishment Types
1
Classifications
5

Registration Details

Registration Name
WIPRO GE HEALTHCARE PRIVATE LTD
Registration Number
9613936
FEI Number
1000571342
Status
Active
Expiry Year
2026
Initial Importer
No
Address
122, Part I, EXPORT PROMOTIONAL INDUSTRIAL PARK
City
WHITEFIELD, BANGALORE Karnataka
Country
IN

Regulatory Submissions

510(k) Number
K143251

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
Phone
262 3092157

Products

Device Name Product Code
System, Nuclear Magnetic Resonance Imaging LNH
System, Nuclear Magnetic Resonance Spectroscopic LNI
Coil, Magnetic Resonance, Specialty MOS
Generator, High-Voltage, X-Ray, Diagnostic IZO
System, Tomography, Computed, Emission KPS

Proprietary Names

SIGNA Explorer SIGNA Creator SIGNA Explorer Quantum SIGNA MR355 SIGNA MR360 Optima MR450w GEM XP Gradient Optima MR450w GEM Optima MR450w 1.5T 8Ch GEM Breast Coil liberty 9000 8-ch breast coil with disposable biopsy plate 1.5T HD Breast Array Lateral Large Grid Biopsy Plate Medial Large Grid Breast Biopsy Plate 1.5T HD Flat GEM Table Breast Array Discovery MR750 3T DISCOVERY MR 750- 3T SPLIT HEAD COIL Discovery MR750 System GP Flex Coil 1T. GP Flex Coil 1.5T Discovery MR750w 3T Discovery MR750W MR 750W 3T GEM PA (Aurora only) 3T GEM HNU (Aurora only) 3T GEM PVA (Aurora only) 3T GEM Anterior Array (Aurora only) 1.5T SPLIT HEAD COIL 3T SPLIT HEAD COIL 3T GE Signa Excite HD MR System 1.5T GE Signa Excite HD MR System 1.5T Signa HD premier 9000 8 channel phased array 1.5T, 8Ch CTL coil-HDx CTL 8 Channel CTL Coil Signa HD 1.5T 8-Ch CTL Coil 1.5T HD 8 CH CTL Coil 1.5T 8 CH CTL Coil Signa Excite 1.5T Expert. SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY 5" ROUND COIL 1.5T 3" ROUND COIL 1.5T 3T SIGNA HDxt Mobile SIGNA VIBRANT 3T SIGNA HDXt 1.5T SIGNA HDXt 1.5T Signa HDxt Mobile 1.5T 4CH Large Flex Coil 1.5T 4CH Small Flex Coil 9E Express AA coil 16CH Express HNA coil 8ch Express PA coil 1.5T EXPRESS COIL - 16E HEAD NECK ARRAY 1.5T EXPRESS COIL - 9E ANTERIOR ARRAY DISCOVERY MR 450-1.5T SPLIT HEAD COIL Discovery MR450 3T HD Breast Array 3T 8Ch GEM Breast Coil 3T HD FLAT GEM Table Breast Array GE 1.5T SIGNA HDE MR SYSTEM 8ch Express Suite Optima MR360 Brivo MR355 EXPRESS COIL - HEAD NECK ARRAY EXPRESS COIL - ANTERIOR ARRAY EXPRESS COIL - POSTERIOR ARRAY 1.5T, 4 CH. CTL SPINE COIL, Premier 7000 CTL Spine coil Signa HD 1.5T CTL Spine Coil PHASED ARRAY-HDe 1.5T 4 Ch. Premier 7000 CTL Coil Signa HDe 1.5T 4CH CTL Spine Coil Signa HDi 1.5T GE 3T Signa HDxt MR System Signa HDi GE 1.5T Signa HDx MR System GE 1.5T Signa HDxt MR System GE 3T Signa HDx MR System Signa Vibrant Jedi TTH Jedi80RF1T Jedi80R1T Jedi 80 RD 1T Jedi42CT Jedi 50 Plus R1T ZEUS Zyx Jedi 80 RF 1T Jedi50R1T JEDI 80 RF1T Jedi 50 R 1T Jedi NP+V1.5 TTH MAESTRO TTH HAWKEYE DMR JEDI 60 DC Jedi 60 DC Djinn Mammo Jedi80RF2T Prisme Jedi 42 CT JEDI SC FAST kV DJINN BEETLE VMX MPPU JEDI HP JEDI 100 VASC 1T CT MINI Jedi60CT X-Ray Generator ZJ/QJ Prodigy/DPX Series High Voltage Power Supply Jedi 60 DC LITE SYJ MPG50 JEDI 60 DC LITE Jedi 60DC Lite MPG100 VAMP Jedi 80 RF 2T JEDI VCT Jedi 80 R 1T TTH 8800 ZEUS, ZJ/QJ Jedi 100 VASC 1 BONZAI Djinn Beetle Jedi 60 CT Jedi 60DC GAIA INTERVENTIONAL GENERATOR Djinn Tonix 1.5T Split Head Coil Optima MR 450w GEM Optima MR450w 1.5T Discovery MR450 1.5T Optima MR 450w Discovery IQ Discovery IQ Clarity GE 3T General Purpose Flex Coil

Establishment Types

Manufacture Medical Device