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Sekisui Diagnostics LLC

USA · San Diego CA · www.sekisuidiagnostics.com

✓ Record-verifiedregistrations found in 11 marketsEU SRN US-MF-000025170

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, 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

1UDI-DI device records

IVD general 1

USUnited StatesFDA openFDA

67listed device types

Class I 29Class II 37Class III 0unclassified 1

plus 140 registration records and 12 510(k)

UKUnited KingdomMHRA PARD

20registered device records

IVD C 8IVD general 9Class B – Self-testing or Near-patient Testing 2Class C – Self-testing or Near-patient Testing 1

BRBrazilANVISA

12registered devices

Class II 12

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

23active device licences

Class II 21Class III 2

86 including historic records

TWTaiwanTFDA

13valid device licences

Class I 11Class II 2

SGSingaporeHSA SMDR

10device registrations

CLASS B 9CLASS C 1

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

IVD import 4

AUAustraliaTGA ARTG

2active ARTG entries

IVD Class 2 2

HKHong KongMDACS

5valid listings

IVD B 1IVD C 4

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

2active registrations

Class 1 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.

European Union1 raw hits, 0 excluded, 1 confirmed

United States140 registration records, 12 510(k), 0 PMA, 3 excluded

United Kingdom20 confirmed, 1 excluded

Brazil12 confirmed, 0 excluded

Canada23 confirmed, 0 excluded

Manufacturer names merged into this page: Sekisui Diagnostics, LLC · Sekisui Diagnostics P.E.I. Inc. · SEKISUI DIAGNOSTICS P.E.I. INC. · SEKISUI DIAGNOSTICS, LLC · SEKISUI DIAGNOSTIC, LLC · SEKISUI DIAGNOSTICS P.E.I. INC

Regulatory identity

EU manufacturer SRN: US-MF-000025170
EU authorised representative: MDSS GmbH
UK responsible person: Sekisui Diagnostics (UK) Ltd

FDA 510(k) clearances by year

12011

22012

12016

32018

22019

12020

12022

12025

FDA listed device types

showing 8 of 67

Phosphomolybdate (Colorimetric), Inorganic Phosphorus 1Ferrozine (Colorimetric) Iron Binding Capacity 1Enzyme Linked Immunoabsorbent Assay, Rotavirus 1Ldl & Vldl Precipitation, Hdl 1Enzymatic Method, Ammonia 1Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1Antisera, All Groups, Streptococcus Spp. 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	D-198ECK	OSOM® RSV/Adeno Control Kit	IVD general
UK	51707	OSOM	Class B – Self-testing or Near-patient Testing
UK	49689	OSOM	IVD general
UK	49119	OSOM	Class B – Self-testing or Near-patient Testing
US	K241188	Acucy® Influenza A&B Test with the Acucy® 2 System	2025-04-18
US	K202644	Acetaminophen	2022-02-18
US	K192719	Osom Ultra Plus Flu A&B Test Kit	2020-04-03
BR	80146502197	Família Alinity c Salicylate	Class II
BR	80146501562	DIRECT LDL / LDL DIRETO	Class II
BR	80096210001	REAGENTE LIQUID N-GENEOUS HDL-COLESTEROL	Class II
CA	1041	AMYLASE ASSAY	Class II
CA	1340	ACID PHOSPHATASE ASSAY	Class II
CA	1341	BILIRUBIN (DIRECT) ASSAY	Class II