Home›Israel›Philips Medical Systems Technologies , Ltd.

Philips Medical Systems Technologies , Ltd.

Israel · Haifa

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, South Korea — 6 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

39listed device types

Class I 5Class II 34Class III 0

plus 90 registration records and 226 510(k), 63 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 2Class II 2

53 including historic records

SASaudi ArabiaSFDA

141registered imported devices

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

CACanadaMDALL

76active device licences

Class II 49Class III 24Class IV 3

125 including historic records

TWTaiwanTFDA

8valid device licences

Class II 8

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

Import 4

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 States90 registration records, 226 510(k), 63 PMA, 97 excluded

Brazil4 confirmed, 18 excluded

Saudi Arabia141 confirmed, 13 excluded

Canada76 confirmed, 27 excluded

Manufacturer names merged into this page: Philips Medical Systems Ltda · PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD. · Philips Medical Systems Technologies Ltd. · Philips Medical Systems Technologies Ltd · PHILIPS MEDICAL SYSTEMS · PHILIPS MEDICAL SYSTEMS.

FDA 510(k) clearances by year

72005

52006

82007

72008

42009

52010

82011

42012

72013

42014

42015

42016

32017

22018

12019

22020

32021

22024

22025

32026

FDA listed device types

showing 8 of 39

System, Network And Communication, Physiological Monitors 1Detector And Alarm, Arrhythmia 1System, Planning, Radiation Therapy Treatment 1Amplifier And Signal Conditioner, Transducer Signal 1Antimicrobial Blood Pressure Cuff 1Oximeter, Ear 1System, X-Ray, Tomography, Computed 1Oximeter 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253670	SmartCT (R3.0 (L10))	2026-07-10
US	K253649	Spectral CT Verida Family	2026-03-27
US	K254186	Azurion R3.1	2026-01-16
BR	10216710382	IntelliSpace Precision Medicine Pathology Genomics Workspace	Class II
BR	10216710197	CENTRAL DE PROCESSAMENTO DE IMAGENS MÉDICAS	Class I
BR	10216710396	IntelliSpace ECG	Class II
SA	ME0000009235SFDAA00001	Disposable Abdominal Belt	—
SA	ME0000009235SFDAA00002	Efficia 50mm Chemical Thermal Paper, No Gridlines	—
CA	1108	EASI VIEW	Class II
CA	1386	WALLABY 3 PHOTOTHERAPY SYSTEM	Class III
CA	6903	PULSE OXIMETER	Class III

Philips Medical Systems Technologies , Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies