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Philips Medizin Systeme

Germany · Boblingen

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Hong Kong, Israel, Russia — 9 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

76listed device types

Class I 10Class II 66Class III 0

plus 102 registration records and 71 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

15 including historic records

SASaudi ArabiaSFDA

58registered imported devices

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

CACanadaMDALL

33active device licences

Class II 13Class III 20

106 including historic records

TWTaiwanTFDA

6valid device licences

Class II 6

SGSingaporeHSA SMDR

16device registrations

CLASS B 5CLASS C 11

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

16valid listings

Class II 1Class III 15

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

7active registrations

Class 2a 1Class 2b 6

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 States102 registration records, 71 510(k), 0 PMA, 14 excluded

Brazil3 confirmed, 4 excluded

Saudi Arabia58 confirmed, 4 excluded

Canada33 confirmed, 3 excluded

Manufacturer names merged into this page: Philips Medizin Systeme Boeblingen GmbH · PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH · Philips Medizin Systeme Boblingen GmbH

FDA 510(k) clearances by year

72006

42008

12009

32010

12011

22012

22013

12014

42015

12016

32017

42018

32019

12020

22021

12022

42023

22024

62025

42026

FDA listed device types

showing 8 of 76

System, Network And Communication, Physiological Monitors 1Detector And Alarm, Arrhythmia 1Electrocardiograph, Ambulatory (Without Analysis) 1Index-Generating Electroencephalograph Software 1Uterine Electromyographic Monitor 1Amplifier And Signal Conditioner, Transducer Signal 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252821	Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)	2026-05-29
US	K253887	Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)	2026-05-01
US	K253654	IntelliVue Measurement Rack 6000 (867317)	2026-03-30
BR	10216719035	Estação de Trabalho Cardíaco Cardiac Workstation	Class II
BR	10216710222	Eletrocardiógrafo Pagewriter	Class II
BR	10216719030	Eletrocardiógrafo Pagewriter	Class II
SA	ME0000003253SFDAA00042	IntelliVue CL Charging Station	—
SA	ME0000003253SFDAA00024	M1646A PICCO Temperature Probe	—
CA	1135	NEONATAL HAND/FOOT SP02 SENSOR	Class II
CA	6085	ANESTHETIC GAS MONITOR CONNECTION SYSTEM	Class II
CA	12826	NIBP (NON-INVASIVE BLOOD PRESSURE) MONITORING ACCESSORIES	Class II

Philips Medizin Systeme

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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