PREANALYTIX GMBH

Switzerland · Hombrechtikon Zurich

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Taiwan, Australia, Israel — 5 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

2listed device types

Class I 0Class II 2Class III 0

plus 2 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 2

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

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IVD Class 1 1IVD Class 2 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

pendingnot queried

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 States2 registration records, 4 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Manufacturer names merged into this page: PREANALYTIX GMBH

FDA 510(k) clearances by year

12005 · DEN050003

12009 · K082150

12015 · K142821

12023 · K231469

FDA listed device types

Blood/Plasma Collection Device For Dna Testing 1System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K231469	PAXgene® Blood DNA Tube	2023-06-21
US	K142821	PAXgene Blood DNA Tube	2015-09-09
US	K082150	MODIFICATION TO PAXGENE BLOOD RNA SYSTEM	2009-02-04
BR	10033430902	Tubo PAXgene Blood DNA	Class I
BR	10033430514	Tubo PAXgene Blood RNA	Class I

PREANALYTIX GMBH

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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