Home›Brazil›PHILIPS MEDICAL SYSTEMS INDUSTRIA E COMERCIO LTDA

PHILIPS MEDICAL SYSTEMS INDUSTRIA E COMERCIO LTDA

Brazil

✓ 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

32listed device types

Class I 5Class II 27Class III 0

plus 23 registration records and 221 510(k), 63 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 3Class II 4

56 including historic records

SASaudi ArabiaSFDA

141registered imported devices

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

CACanadaMDALL

74active device licences

Class II 49Class III 22Class IV 3

123 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 States23 registration records, 221 510(k), 63 PMA, 102 excluded

Brazil7 confirmed, 18 excluded

Saudi Arabia141 confirmed, 13 excluded

Canada74 confirmed, 28 excluded

Manufacturer names merged into this page: Philips Medical Systems Ltda · PHILIPS MEDICAL SYSTEMS · PHILIPS MEDICAL SYSTEMS. · PHILIPS MEDICAL SYSTEMS LTDA · PHILIPS MEDICAL SYSTEMS INDUSTRIA E COMERCIO LTDA · Philips Medical Systems

FDA 510(k) clearances by year

112004

72005

52006

82007

72008

42009

52010

82011

42012

72013

42014

42015

42016

32017

12018

12019

22020

32021

12025

22026

FDA listed device types

showing 8 of 32

System, Network And Communication, Physiological Monitors 1Detector And Alarm, Arrhythmia 1Amplifier And Signal Conditioner, Transducer Signal 1Antimicrobial Blood Pressure Cuff 1Oximeter, Ear 1Oximeter 1Transmitters And Receivers, Physiological Signal, Radiofrequency 1Spirometer, Monitoring (W/Wo Alarm) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253670	SmartCT (R3.0 (L10))	2026-07-10
US	K254186	Azurion R3.1	2026-01-16
US	K251827	Azurion R3.1	2025-10-24
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 INDUSTRIA E COMERCIO LTDA

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