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Philips Clinical Informatics

Brazil · Blumenau Santa Catarina
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, South Korea — 3 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
4listed device types
Class I 1Class II 3Class III 0
plus 15 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
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
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
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 States15 registration records, 2 510(k), 0 PMA, 10 excluded
Brazil0 confirmed, 1 excluded
Canada1 confirmed, 2 excluded
Manufacturer names merged into this page: Philips India Limited - Radiology Informatics, Clinical Informatics, Patient Care Informatics Business Units · Philips Clinical Informatics · PHILIPS HEALTHCARE INFORMATICS, INC.
Same-named companies — This database also contains companies with near-identical names: Philips Healthcare Informatics, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Brazil
City
Blumenau Santa Catarina

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

12011 · K111804
12018 · K182926

FDA listed device types

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Computer, Diagnostic, Programmable 1System, Image Processing, Radiological 1System, Digital Image Communications, Radiological 1

Registration details (sample)

MarketIdentifierNameClass / date
USK182926IntelliSpace Radiology2018-12-06
USK111804INTELLISPACE PACS 4.X2011-07-28
CA62673PACSClass II

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