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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V..

Netherlands · Orange Village

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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

42listed device types

Class I 13Class II 29Class III 0

plus 335 registration records and 112 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

17registered devices

Class I 1Class II 16

27 including historic records

SASaudi ArabiaSFDA

17registered imported devices

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

CACanadaMDALL

94active device licences

Class II 56Class III 38

210 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

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 States335 registration records, 112 510(k), 0 PMA, 6 excluded

Brazil17 confirmed, 0 excluded

Saudi Arabia17 confirmed, 0 excluded

Canada94 confirmed, 2 excluded

Manufacturer names merged into this page: Philips Medical Systems Nederland B.V. · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V

Same-named companies — This database also contains companies with near-identical names: Philips Electronics Nederland B.V., Philips Medical System Nederland B.V.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

22005

12009

12010

12011

12012

112013

62014

32015

82016

132017

102018

42019

72020

82021

62022

42023

92024

82025

92026

FDA listed device types

showing 8 of 42

System, Network And Communication, Physiological Monitors 1System, Planning, Radiation Therapy Treatment 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Whole Slide Imaging System 1Accelerator, Linear, Medical 1Holder, Head, Neurosurgical (Skull Clamp) 1System, X-Ray, Tomography, Computed 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	10216710403	Tasy Java	Class II
BR	10216710404	Tasy EMR	Class II
BR	10216710405	Tasy Delphi	Class II
SA	ME0000003237SFDAA00096	Onvision System	—
SA	ME0000003237SFDAA00123	Assy Cerebral Filter	—
CA	17997	PQS COMPUTED TOMOGRAPHY SYSTEM	Class III
CA	18125	PREMIER XTRA CT IMAGING SYSTEM	Class III
CA	15813	VANTAGE NON-UNIFORM ATTENUATION CORRECTION SYSTEM	Class II

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V..

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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