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Sign in to claim this brandWipro GE Healthcare Private Ltd
India·IN-MF-000016100
Last updated September 17, 2026
What Wipro GE Healthcare Private Ltd makes
The company manufactures fetal and maternal monitoring devices, including reusable electrode/transducer straps and tocodynamometer probes for real-time monitoring. Their portfolio includes telemetric cardiotocography systems for prenatal care, such as the Mini Telemetry System and the COROMETRICS 170 Series, designed for continuous assessment of fetal heart rate and uterine contractions. Single-patient-use transducer belts are also part of their offerings.
These devices are classified under Class I and Class II regulations, with listings in the EUDAMED database, FDA’s 510(k) premarket notifications, and FDA’s Unique Device Identifier (UDI) system. The company is based in India.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Wipro GE Healthcare Private Ltd manufacture?
Wipro GE Healthcare Private Ltd specializes in fetal and maternal monitoring devices. Their portfolio includes reusable electrode/transducer straps, tocodynamometer probes, and telemetric cardiotocography systems like the Mini Telemetry System and COROMETRICS 170 Series. These devices are designed for real-time monitoring of fetal heart rate and uterine contractions during prenatal care.
Where is Wipro GE Healthcare Private Ltd based?
The company is headquartered in India, as indicated by its regulatory listings and device documentation.
Which regulatory registries list devices manufactured by Wipro GE Healthcare Private Ltd?
Devices from Wipro GE Healthcare Private Ltd are listed in the EUDAMED database, the FDA’s 510(k) premarket notification system, and the FDA’s Unique Device Identifier (UDI) system. These registries help track and authorize medical devices globally.
How are the devices manufactured by Wipro GE Healthcare Private Ltd classified?
The company’s devices fall under Class I and Class II regulatory classifications. Class I devices generally pose minimal risk and may require fewer regulatory controls, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification depends on the specific device type and its intended use.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- India
- Address
- 04, Kadugodi Industrial Area, Bangalore, India
- Website
- gehealthcare.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Kumuda TS
- EUDAMED SRN
- IN-MF-000016100
- FDA FEI Number
- 3007734888
- DUNS Number
- —
Catalogue (23)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Transducer Belt – Button - Single Patient Use | 2016354-001 | EUDAMED | Class I | Active |
| TRANSDUCER BELT – BUTTON - SINGLE PATIENT USE – 200/Box | 2015919-001 | EUDAMED | Class I | Active |
| Mini Telemetry System | 2051444-003 | FDA UDI | Class II | Active |
| Mini Telemetry System | 2051440-002 | FDA UDI | Class II | Active |
| Corometrics 170 Series | MODEL 171 | FDA UDI | Class II | Active |
| Transducer Belt - Button - Single Patient Use - 10 Box | B1 | EUDAMEDFDA UDI | Class I | Active |
| Mini Telemetry System | 2051444-002 | FDA UDI | Class II | Active |
| Mini Telemetry System | 2051440-003 | FDA UDI | Class II | Active |
| Mini Telemetry System | 2051444-004 | FDA UDI | Class II | Active |
| Corometrics 170 Series | MODEL 172 | FDA UDI | Class II | Active |
| Mini Telemetry System | 2051444-001 | FDA UDI | Class II | Active |
| Mini Telemetry System | 2051440-001 | FDA UDI | Class II | Active |
| Toco Transducer | NA | EUDAMEDFDA UDI | Class II | Active |
| Mini Telemetry System | 2051440-004 | FDA UDI | Class II | Active |
| Ultrasound Transducer | NA | FDA UDI | Class II | Active |
| Coro - Round MECG cable AHA | MECG1 | FDA UDI | Class II | Unknown |
| Corometrics 250cx Series | MODEL 259CX | FDA UDI | Class II | Active |
| Corometrics 170 Series | MODEL 174 | FDA UDI | Class II | Active |
| Lullaby Led Phottherapy System | K120168 | FDA 510(k) | Class II | Active |
| 1.5t 4ch Large Flex Coil, 1.5 4ch Small Flex Coil | K123681 | FDA 510(k) | Class II | Active |
| Mini Telemetry System | K110556 | FDA 510(k) | Class II | Active |
| Lullaby Tm Warmer | K121625 | FDA 510(k) | Class II | Active |
| Ge Vivid P3 Diagnostic Ultrasound Imaging System | K102104 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Wipro GE Healthcare Private Ltd. Bangalore Karnataka · IN FEI 3003190524