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TOSOH BIOSCIENCE, INC.

USA · Grove City

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Russia — 4 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

57listed device types

Class I 17Class II 38Class III 2

plus 97 registration records and 20 510(k), 10 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 2Class II 1

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

0active device licences

2 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

4active registrations

Class 1 3Class 2b 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 States97 registration records, 20 510(k), 10 PMA, 6 excluded

Brazil3 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: TOSOH BIOSCIENCE, INC. · TOSOH BIOSCIENCE

FDA 510(k) clearances by year

12007

12008

12009

22010

22011

12012

12013

42014

32015

12016

22021

12025

FDA listed device types

showing 8 of 57

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

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250073	Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01	2025-10-03
US	K211199	ST AIA-PACK BNP Assay	2021-11-08
US	K200904	Tosoh Automated Glycohemoglobin Analyzer HLC-723G8	2021-08-05
BR	80915630004	Solução de Lavagem & Hemolisante HSI	Class I
BR	81298810125	HSi Hemolysis & Wash Solution-(L) - (HSi Solução de Lavagem e Hemólise	Class I
BR	81298810131	Hemoglobin A1c Controls - Levels 1 and 2 (Controles para Hemoglobina A	Class II

TOSOH BIOSCIENCE, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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