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Hitachi Chemical Diagnostics, Inc.

USA · Mountain View

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Israel, 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

16510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 16 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

1active device licences

Class II 1

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 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 States0 registration records, 16 510(k), 0 PMA, 23 excluded

Brazil0 confirmed, 2 excluded

Canada1 confirmed, 1 excluded

Manufacturer names merged into this page: HITACHI CHEMICAL DIAGNOSTICS, INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K193613	Allergen-Specific IgE Assay 12 Allergen Bundle	2021-10-18
US	K182793	AP3600 Automated Instrument	2019-03-19
US	K140248	S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)	2014-03-11
CA	61634	CLA-1 LUMINOMETER ALLERGY SYSTEM	Class II

Hitachi Chemical Diagnostics, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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