Home›Germany›QIAGEN, GMBH

QIAGEN, GMBH

Germany · Hilden

✓ 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

26listed device types

Class I 10Class II 11Class III 4unclassified 1

plus 35 registration records and 17 510(k), 120 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

50registered devices

Class I 35Class II 15

69 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

8active device licences

Class III 8

14 including historic records

TWTaiwanTFDA

22valid device licences

Class I 9Class II 5Class III 8

SGSingaporeHSA SMDR

11device registrations

CLASS B 2CLASS C 7CLASS D 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

11active ARTG entries

IVD Class 1 4IVD Class 2 1IVD Class 3 6

HKHong KongMDACS

21valid listings

IVD C 21

ILIsraelAMAR

26registrations

RURussiaRoszdravnadzor

15active registrations

Class 1 2Class 2a 9Class 2b 3Class 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 States35 registration records, 17 510(k), 120 PMA, 1 excluded

Brazil50 confirmed, 3 excluded

Canada8 confirmed, 3 excluded

Manufacturer names merged into this page: QIAGEN, GMBH · QIAGEN · QIAGEN GMBH

FDA 510(k) clearances by year

22012

22014

12017

12018

12019

42024

42025

22026

FDA listed device types

showing 8 of 26

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis 1Placental Alpha Microglobulin-1 Immunoassay 1Somatic Gene Mutation Detection System 1Kit, Dna Detection, Human Papillomavirus 1Dna-Reagents, Neisseria 1Spatula, Cervical, Cytological 1Jak2 Gene Mutation Detection Test 1System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K254194	QIAstat-Dx BCID GPF Plus AMR Panel	2026-08-06
US	K254032	QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B	2026-03-09
US	K252329	QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B	2025-10-22
BR	10322250012	QUIMIOLUMINÔMETRO DML 2000 DIGENE SISTEMA LUMINÔMETRO EM MICROPLACA	Class II
BR	10322250018	KIT DE COLETA DOS ESPÉCIMES	Class I
BR	10322250136	PartoSure Test	Class II
CA	75329	ARTUS HBV LC PCR KIT	Class III
CA	93689	QIASYMPHONY DSP HPV MEDIA KIT	Class III
CA	97247	THERASCREEN EGFR RGQ PCR KIT	Class III