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Maquet GmbH and Co. KG

Germany · Rastatt

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, 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

12listed device types

Class I 8Class II 4Class III 0

plus 14 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

13registered devices

Class I 7Class II 6

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

386registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

3 including historic records

TWTaiwanTFDA

12valid device licences

Class I 6Class II 6

SGSingaporeHSA SMDR

4device registrations

CLASS B 1CLASS C 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

42active ARTG entries

Class I 39IIa 1IIb 2

HKHong KongMDACS

3valid listings

Class III 3

ILIsraelAMAR

14registrations

RURussiaRoszdravnadzor

8active registrations

Class 1 4Class 2a 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 States14 registration records, 5 510(k), 0 PMA, 15 excluded

Brazil13 confirmed, 9 excluded

Saudi Arabia386 confirmed, 3 excluded

Canada1 confirmed, 4 excluded

Manufacturer names merged into this page: MAQUET GMBH · MAQUET GMBH & CO. KG · Maquet GmbH · Maquet SAS · MAQUET SAS

FDA 510(k) clearances by year

12004 · K030071

12009 · K092903

12018 · K172159

12021 · K201927

12022 · K214120

FDA listed device types

showing 8 of 12

Table, Surgical With Orthopedic Accessories, Ac-Powered 1Hook, Bone 1Surgical Table Cushion 1Table, Operating-Room, Manual 1Table, Operating-Room, Ac-Powered 1Holder, Head, Radiographic 1Table And Attachments, Operating-Room 1Headrest, Neurosurgical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K214120	GSS610N21 Series Steam Sterilizer	2022-05-18
US	K201927	Getinge GSS610N Series Steam Sterilizer	2021-03-01
US	K172159	Getinge GSS67N Series Steam Sterilizer	2018-01-30
BR	80978563690	SUPORTE DE BRAÇO TRIMANO	Class I
BR	80259110131	Esterilizadores a Vapor GSS67H	Class II
BR	80259110076	SISTEMA DE INTEGRAÇÃO CIRÚRGICA TEGRIS	Class I
SA	ME0000003539SFDAA00138	Corded Hand Control	—
SA	ME0000003539SFDAA00139	IR Remote Control	—
CA	85494	BORA	Class II

Maquet GmbH and Co. KG

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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