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DiaSorin Italia S.p.A.

Italy · Saluggia Vercelli

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 9 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

42listed device types

Class I 14Class II 21Class III 3unclassified 4

plus 65 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

55registered devices

Class I 7Class II 48

143 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

92valid device licences

Class I 27Class II 63Class III 2

SGSingaporeHSA SMDR

10device registrations

CLASS B 3CLASS C 6CLASS D 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

42active ARTG entries

IVD Class 1 2IVD Class 2 6IVD Class 3 20IVD Class 4 14

HKHong KongMDACS

4valid listings

IVD C 4

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

5active registrations

Class 1 4Class 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 States65 registration records, 0 510(k), 0 PMA, 10 excluded

Brazil55 confirmed, 8 excluded

Canada0 confirmed, 3 excluded

Manufacturer names merged into this page: DiaSorin Italia S.p.A. · DiaSorin Italia S.p.A UK Branch · DIASORIN ITALIA S.P.A. UK BRANCH · DIASORIN ITALIA S.P.A. · DIASORIN ITÁLIA S.P.A

FDA listed device types

showing 8 of 42

Hepatitis A Test (Antibody And Igm Antibody) 1Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus 1Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens 1Device To Detect Antibodies To Hepatitis D Virus 1Radioimmunoassay, Thyroid-Stimulating Hormone 1Antigen, Inflammatory Response Marker, Sepsis 1Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 1Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster 1

Market	Identifier	Name	Class / date
BR	10339840276	LIAISON CONTROL CARDIOLIPIN IgG	Class II
BR	10339840288	LIAISON CONTROL DHEA-S	Class II
BR	10339840278	LIAISON CARDIOLIPIN IgM	Class II

DiaSorin Italia S.p.A.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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