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DIESSE Diagnostica Senese S.p.A.

✓ Record-verifiedregistrations found in 11 marketsEU SRN IT-MF-000013311

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 11 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

100UDI-DI device records

IVD A 9IVD B 65IVD C 26

USUnited StatesFDA openFDA

17listed device types

Class I 16Class II 1Class III 0

plus 18 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

93registered device records

IVD A 9IVD B 23IVD C 39IVD general 22

BRBrazilANVISA

8registered devices

Class I 1Class II 7

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

9active device licences

Class II 8Class III 1

13 including historic records

TWTaiwanTFDA

62valid device licences

Class I 25Class II 37

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

11active ARTG entries

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

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

8registrations

RURussiaRoszdravnadzor

20active registrations

Class 1 1Class 2a 16Class 2b 3

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.

European Union100 raw hits, 0 excluded, 100 confirmed

United States18 registration records, 2 510(k), 0 PMA

United Kingdom93 confirmed, 0 excluded

Brazil8 confirmed, 0 excluded

Canada9 confirmed, 0 excluded

Manufacturer names merged into this page: DIESSE DIAGNOSTICA SENESE S.P.A · DIESSE DIAGNOSTICA SENESE S.P.A. · DIESSE DIAGNÓSTICA SENESE S.P.A · DIESSE DIAGNOSTICA SENESE SPA

Regulatory identity

EU manufacturer SRN: IT-MF-000013311
UK responsible person: IVDeology UKRP Ltd

Business registration

LEI: 815600B94C1EC7D90683
Registration status: Active
Legal form: Società Per Azioni (SPA)
Incorporated: 1980-07-01
Registered address: VIALE DECUMANO, 36, MILANO, 20157
Registration authority: Business Register, no. 05871140157
Registry record updated: 2026-08-28

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12006 · K050590

12007 · K070062

FDA listed device types

showing 8 of 17

Enzyme Linked Immunoabsorbent Assay, Rubeola Igg 1Test, Erythrocyte Sedimentation Rate 1Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus 1Device, Automated Sedimentation Rate 1P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin 1Tube, Sedimentation Rate 1Antigen, Agglutinating, Echinococcus Spp. 1Antigen, Cf, Q Fever 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08033891324605	CHORUS MPO	IVD B
EU	08033891324599	CHORUS MPO	IVD B
EU	08033891329150	CHORUS SS-A	IVD B
EU	08033891323189	CHORUS SS-A	IVD B
UK	62369	CHORUS CLIA 25OH VITAMIN D TOTAL	IVD B
UK	64179	AUTO-DAT	IVD A
UK	54870	CHORUS CARDIOLIPIN-G	IVD B
US	K070062	COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE	2007-07-30
US	K050590	ENZY-WELL SYPHILIS IGG, MODEL 91106	2006-08-10
BR	81692610036	VES-MATIC CUBE	Class I
BR	81692610077	Mini Cube	Class II
BR	10300390691	ESR Control Cube	Class II
CA	60464	VESMATIC 30 ESR SYSTEM	Class II
CA	60531	MINIVES ESR SYSTEM	Class II
CA	70743	VES-MATIC ESR INSTRUMENTS	Class II