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WIPRO GE MEDICAL DEVICE MANUFACTURING PRIVATE LIMITED

India · Bangalore Karn?Taka

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Singapore, South Korea, Israel, Russia — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

63listed device types

Class I 7Class II 56Class III 0

plus 280 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

5 including historic records

SASaudi ArabiaSFDA

2registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

4active device licences

Class III 4

11 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

6active registrations

Class 2a 2Class 2b 4

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States280 registration records, 6 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Saudi Arabia2 confirmed, 0 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: Wipro GE Healthcare Private Ltd. · WIPRO GE MEDICAL DEVICE MANUFACTURING PRIVATE LIMITED · WIPRO GE HEALTHCARE PRIVATE Ltd. · WIPRO GE HEALTHCARE PRIVATE LTD · WIPRO GE HEALTHCARE PRIVATE LTD. · WIPRO GE HEALTHCARE PRIVATE LIMITED

FDA 510(k) clearances by year

12010 · K102104

12011 · K110556

22012 · K121625

12013 · K123681

12014 · K133622

FDA listed device types

showing 8 of 63

Detector And Alarm, Arrhythmia 1Uterine Electromyographic Monitor 1Index-Generating Electroencephalograph Software 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1System, X-Ray, Mobile 1Electrode, Electrocardiograph 1Oximeter, Ear 1Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K133622	MAC 2000 ECG ANALYSIS SYSTEM	2014-01-23
US	K123681	1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL	2013-02-22
US	K121625	LULLABY TM WARMER	2012-09-14
BR	80071260194	ELETROCARDIÓGRAFO MAC 400	Class II
BR	80071260201	MONITOR SÉRIE 250CX COROMETRICS	Class II
BR	80071260210	MONITOR FETAL COROMETRICS 170	Class II
SA	ME0000003355SFDAA00010	Transducer Belt	—
SA	ME0000003355SFDAA00009	TOCO Transducer	—
CA	14123	LOGIQ 100 PRO ULTRASOUND SYSTEM	Class III
CA	63817	LOGIQ 3 ULTRASOUND SYSTEM	Class III
CA	69223	LOGIQ 3 PRO ULTRASOUND SYSTEM	Class III

WIPRO GE MEDICAL DEVICE MANUFACTURING PRIVATE LIMITED

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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