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Philips Medical Systems B.V.

Netherlands · Best

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

82listed device types

Class I 19Class II 63Class III 0

plus 474 registration records and 659 510(k), 82 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

26registered devices

Class I 6Class II 20

86 including historic records

SASaudi ArabiaSFDA

194registered imported devices

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

CACanadaMDALL

202active device licences

Class II 124Class III 75Class IV 3

418 including historic records

TWTaiwanTFDA

3valid device licences

Class I 1Class III 2

SGSingaporeHSA SMDR

44device registrations

CLASS B 20CLASS C 24

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

58active ARTG entries

Class I 41IIa 9IIb 8

HKHong KongMDACS

13valid listings

Class II 5Class III 8

ILIsraelAMAR

29registrations

RURussiaRoszdravnadzor

5active registrations

Class 2a 1Class 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 States474 registration records, 659 510(k), 82 PMA, 79 excluded

Brazil26 confirmed, 13 excluded

Saudi Arabia194 confirmed, 8 excluded

Canada202 confirmed, 20 excluded

Manufacturer names merged into this page: Philips Medical Systems Nederland B.V. · Philips Medical Systems Ltda · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD. · PHILIPS MEDICAL SYSTEMS · INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS

FDA 510(k) clearances by year

102007

132008

112009

82010

122011

52012

202013

142014

122015

182016

222017

152018

72019

112020

152021

72022

52023

152024

102025

122026

FDA listed device types

showing 8 of 82

System, Network And Communication, Physiological Monitors 1Detector And Alarm, Arrhythmia 1System, Planning, Radiation Therapy Treatment 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1Amplifier And Signal Conditioner, Transducer Signal 1System, X-Ray, Mobile 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Antimicrobial Blood Pressure Cuff 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K254205	Zenition 30	2026-08-07
US	K262330	dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T	2026-07-30
US	K262294	dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T	2026-07-24
BR	10216710382	IntelliSpace Precision Medicine Pathology Genomics Workspace	Class II
BR	10216710403	Tasy Java	Class II
BR	10216710404	Tasy EMR	Class II
SA	ME0000009230SFDAA00001	Kit, Water Trap, EtCO2, 3160	—
SA	ME0000009235SFDAA00001	Disposable Abdominal Belt	—
CA	1108	EASI VIEW	Class II
CA	1386	WALLABY 3 PHOTOTHERAPY SYSTEM	Class III
CA	6903	PULSE OXIMETER	Class III