Home›Germany›Bruker Daltonics GmbH & Co. KG

Bruker Daltonics GmbH & Co. KG

Germany · Bremen

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 8 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

3listed device types

Class I 0Class II 3Class III 0

plus 5 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

21registered devices

Class I 11Class II 10

22 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

4valid device licences

Class I 3Class II 1

SGSingaporeHSA SMDR

7device registrations

CLASS C 7

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

8active ARTG entries

IVD Class 1 4IVD Class 2 2IVD Class 3 2

HKHong KongMDACS

14valid listings

IVD C 14

ILIsraelAMAR

16registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 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, 3 510(k), 0 PMA

Brazil21 confirmed, 0 excluded

Manufacturer names merged into this page: Bruker Daltonics · BRUKER DALTONICS GMBH & CO. KG

FDA 510(k) clearances by year

12013 · K130831

12015 · K142677

12025 · K251495

FDA listed device types

Mass Spectrometry, Microorganism Identification, Blood Culture 1Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates 1System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251495	MBT Compass HT CA Software; MBT FAST Shuttle US IVD	2025-08-13
US	K142677	MALDI Biotyper CA System	2015-03-27
US	K130831	MALDI BIOTYPER CA (MBT-CA) SYSTEM	2013-11-21
BR	10033430848	MBT STAR-Cepha IVD Kit	Class II
BR	10033430890	MBT Mycobacteria IVD Kit	Class I
BR	10033430860	AST-Reagent Kit	Class I

Bruker Daltonics GmbH & 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)

Similar companies