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MAQUET CRITICAL CARE AB

Sweden · Solna

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

22listed device types

Class I 10Class II 12Class III 0

plus 33 registration records and 20 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

9registered devices

Class II 9

13 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

4active device licences

Class II 1Class III 3

18 including historic records

TWTaiwanTFDA

10valid device licences

Class I 2Class II 8

SGSingaporeHSA SMDR

9device registrations

CLASS B 1CLASS C 8

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

26active ARTG entries

Class I 5IIa 11IIb 10

HKHong KongMDACS

6valid listings

Class II 2Class III 4

ILIsraelAMAR

11registrations

RURussiaRoszdravnadzor

5active registrations

Class 2a 1Class 2b 4

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 States33 registration records, 20 510(k), 0 PMA, 16 excluded

Brazil9 confirmed, 9 excluded

Saudi Arabia0 confirmed, 6 excluded

Canada4 confirmed, 4 excluded

Manufacturer names merged into this page: MAQUET CRITICAL CARE AB · MAQUET CRITICAL CARE AB

FDA 510(k) clearances by year

22004

22007

12008

12010

12011

12012

22014

22015

22017

22019

22020

12021

12023

FDA listed device types

showing 8 of 22

Strap, Head, Gas Mask 1Circuit, Breathing (W Connector, Adaptor, Y Piece) 1Absorber, Carbon-Dioxide 1Set, Tubing And Support, Ventilator (W Harness) 1Cannula, Nasal, Oxygen 1Bag, Reservoir 1Tubing, Pressure And Accessories 1Mask, Gas, Anesthetic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K230173	Servo-air Lite Ventilator System	2023-07-06
US	K201874	Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1	2021-04-20
US	K192604	Servo-air 4.0 Ventilator System	2020-06-18
BR	80259110145	Cateter Edi ENFit	Class II
BR	80259119022	ALOJAMENTO DO SENSOR DE TEMPERATURA DO INJETADO PV4046	Class II
BR	80259110167	Cateter de Termodiluição PiCCO Adulto com Fio Guia de Nitinol Reta	Class II
CA	10764	SERVO VENTILATOR	Class III
CA	25836	POLYTRODE SENSOR	Class III
CA	63004	KION-I	Class III