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PULSION MEDICAL SYSTEMS SE

Germany · Feldkirchen

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, 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

39listed device types

Class I 3Class II 36Class III 0

plus 5 registration records and 12 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

4 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

2device registrations

CLASS C 1CLASS D 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

10active ARTG entries

IIa 4IIb 6

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 3 1

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 States5 registration records, 12 510(k), 0 PMA

Manufacturer names merged into this page: PULSION MEDICAL SYSTEMS SE

FDA 510(k) clearances by year

22000

12002

12006

22007

12010

12011

12012

22018

12020

FDA listed device types

showing 8 of 39

System, Network And Communication, Physiological Monitors 1Detector And Alarm, Arrhythmia 1Amplifier And Signal Conditioner, Transducer Signal 1Analyzer, Gas, Oxygen, Gaseous-Phase 1Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) 1Oximeter 1Probe, Thermodilution 1Transmitters And Receivers, Physiological Signal, Radiofrequency 1

Market	Identifier	Name	Class / date
US	K192169	PulsioFlex Monitoring System with ProAQT Sensor	2020-04-30
US	K171620	PiCCO Catheter	2018-02-21
US	K172259	PulsioFlex Monitoring System	2018-01-18

PULSION MEDICAL SYSTEMS SE

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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