HomeIndiaPhilips India Limited

Philips India Limited

India · Pune
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Singapore, South Korea, Hong Kong, 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
29listed device types
Class I 1Class II 28Class III 0
plus 171 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
1 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
1active device licences
Class II 1
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
6device registrations
CLASS B 1CLASS C 5
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
1valid listings
Class III 1
ILIsraelAMAR
4registrations
RURussiaRoszdravnadzor
5active registrations
Class 2b 5
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 States171 registration records, 2 510(k), 0 PMA, 98 excluded
Brazil0 confirmed, 20 excluded
Saudi Arabia0 confirmed, 14 excluded
Canada1 confirmed, 29 excluded
Manufacturer names merged into this page: Philips India Limited - Radiology Informatics, Clinical Informatics, Patient Care Informatics Business Units · Philips India Limited - Diagnostic X-ray Business Unit · Philips India Limited - Ultrasound Business Unit · Philips India Limited - Magnetic Resonance Business Unit · PHILIPS INDIA LIMITED · Philips India Limited

Company information

Country
India
City
Pune

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12017 · K173187
12021 · K203623

FDA listed device types

showing 8 of 29
System, Planning, Radiation Therapy Treatment 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1System, X-Ray, Mobile 1Continuous, Ventilator, Home Use 1System, X-Ray, Tomography, Computed 1Ventilator, Continuous, Facility Use 1System, Nuclear Magnetic Resonance Spectroscopic 1Image-Intensified Fluoroscopic X-Ray System, Mobile 1

Registration details (sample)

MarketIdentifierNameClass / date
USK203623StentBoost Mobile2021-04-05
USK173187MobileDiagnost M502017-11-16
CA106106STENTBOOST MOBILEClass II

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