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TOSOH CORPORATION

Japan · Tokyo

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Singapore, Israel, Russia — 6 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

63listed device types

Class I 16Class II 44Class III 3

plus 110 registration records and 11 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

111registered devices

Class I 67Class II 44

112 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

3active device licences

Class II 2Class III 1

14 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

4device registrations

CLASS B 3CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 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 States110 registration records, 11 510(k), 0 PMA, 6 excluded

Brazil111 confirmed, 2 excluded

Canada3 confirmed, 1 excluded

Manufacturer names merged into this page: TOSOH CORP. · TOSOH CORPORATION

Business registration

Corporate Number: 5250001010002
Registration status: Active
Registered capital: JPY 55,173,000,000

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

FDA 510(k) clearances by year

51990 · K903628

31991 · K913663

11992 · K923021

22002 · K023239

FDA listed device types

showing 8 of 63

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus 1Radioimmunoassay, Acth 1Calibrator, Secondary 1Test, Cystatin C 1Calibrator, Primary 1Radioimmunoassay, Thyroid-Stimulating Hormone 1Test, Natriuretic Peptide 1System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K023239	AIA-PACK CA 19-9	2002-12-23
US	K023240	ST AIA-PACK CA 19-9	2002-12-23
US	K923021	AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM	1992-07-21
BR	81298810136	Analisador Automatizado de Imunoensaio Enzimático Quimioluminescente A	Class II
BR	81298810137	CL AIA-PACK SAMPLE DILUTING REAGENT A	Class I
BR	81298810138	CL AIA-PACK SAMPLE DILUTING REAGENT B	Class I
CA	19933	AIA-600 II AUTOMATED ENZYME IMMUNOASSAY SYSTEM	Class III
CA	34878	TOSOH AUTOMATED GYCOHEMOGLOBIN ANALYZER HLC-723G7	Class II
CA	67072	AIA-600 II AUTOMATED ENZYME IMMUNOASSAY SYSTEM	Class II

TOSOH CORPORATION

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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