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Dirui Industrial Co., Ltd.

China · Changchun Jilin · en.dirui.com.cn

✓ Record-verifiedregistrations found in 8 marketsEU SRN CN-MF-000001891

This company has registrations in European Union, United States, Brazil, Singapore, South Korea, Australia, Israel, Russia — 8 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

≥300UDI-DI device records

IVD general 300

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

84listed device types

Class I 61Class II 23Class III 0

plus 84 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

177registered devices

Class I 38Class II 139

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

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

8device registrations

CLASS B 8

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

2active ARTG entries

IVD Class 1 1IVD Class 2 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

65active registrations

Class 1 4Class 2a 61

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 Union1,982 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States84 registration records, 1 510(k), 0 PMA

Brazil177 confirmed, 0 excluded

Manufacturer names merged into this page: DIRUI INDUSTRIAL CO., LTD. · DIRUI INDUSTRIAL CO. LTD · DIRUI INDUSTRIAL CO. LTD. · DIRUI INDUSTRIAL CO., LTD

Regulatory identity

EU manufacturer SRN: CN-MF-000001891
EU authorised representative: Emergo Europe B.V.

FDA 510(k) clearances by year

12004 · K040703

FDA listed device types

showing 8 of 84

Diethyldithiocarbamate (Colorimetric), Copper 1Colorimeter, Photometer, Spectrophotometer For Clinical Use 1Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) 1Cholinesterase Test Paper 1Container, Specimen, Sterile 1Phosphomolybdate (Colorimetric), Inorganic Phosphorus 1Ferrozine (Colorimetric) Iron Binding Capacity 1Immunohistochemistry Reagents And Kits 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06925794574145	Fibrin (Fibrinogen) Degradation Products Detection Kit (Latex Immunoturbidimetric Assay)	IVD general
EU	06925794574138	Fibrin (Fibrinogen) Degradation Products Detection Kit (Latex Immunoturbidimetric Assay)	IVD general
EU	06925794517654	Fibrin (Fibrinogen) Degradation Products Detection Kit (Latex Immunoturbidimetric Assay)	IVD general
EU	06925794517647	Fibrin (Fibrinogen) Degradation Products Detection Kit (Latex Immunoturbidimetric Assay)	IVD general
US	K040703	URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS	2004-08-26
BR	80189860269	TIRAS REAGENTES PARA URINÁLISE DIRUI	Class II
BR	80680420113	Determinand Cleaning Liquid	Class I
BR	80680420115	TIRA DE URINA DIRUI FUS-11(II)	Class II