Home›USA›DiaSorin, Inc.

DiaSorin, Inc.

USA · Stillwater

✓ 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

46listed device types

Class I 19Class II 23Class III 1unclassified 3

plus 56 registration records and 72 510(k), 421 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

52registered devices

Class I 14Class II 38

168 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

122active device licences

Class II 100Class III 21Class IV 1

176 including historic records

TWTaiwanTFDA

41valid device licences

Class I 12Class II 29

SGSingaporeHSA SMDR

4device registrations

CLASS B 3CLASS D 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

9active ARTG entries

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

HKHong KongMDACS

1valid listings

IVD B 1

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 2Class 2b 2

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 States56 registration records, 72 510(k), 421 PMA, 9 excluded

Brazil52 confirmed, 7 excluded

Canada122 confirmed, 2 excluded

Manufacturer names merged into this page: DIASORIN INC. · DIASORIN LTDA · DIASORIN SPA · DIASORIN INC

FDA 510(k) clearances by year

12005

32006

32007

52008

22009

12011

22012

102013

22014

22015

42016

32017

32018

22019

42020

42021

32022

12023

12025

12026

FDA listed device types

showing 8 of 46

Hepatitis A Test (Antibody And Igm Antibody) 1Calibrator, Secondary 1Reagent, Borrelia Serological Reagent 1Calprotectin, Fecal 1Calibrator, Multi-Analyte Mixture 1Radioimmunoassay, Aldosterone 1Transferrin, Antigen, Antiserum, Control 1Radioassay, Vitamin B12 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260770	LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX	2026-06-04
US	DEN250032	LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)	2025-12-23
US	K231214	LIAISON VZV IgG HT, LIAISON Control VZV IgG HT	2023-10-27
BR	10339840539	Família LIAISON® FOLATO	Class II
BR	10339840432	LIAISON® Calprotectin	Class II
BR	10339840370	LIAISON® 25 OH Vitamina D TOTAL Diluente de amostras	Class I
CA	12884	VIRONOSTIKA EBV (VCA) IGM ELISA KIT	Class III
CA	12898	VIRONOSTIKA EBV (VCA) IGG ELISA KIT	Class III
CA	12899	VIRONOSTIKA EBV (EBNA) IGG ELISA KIT	Class III