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Diagnostic Automation / Cortez Diagnostics Inc.

USA · Woodland Hills CA · www.rapidtest.com

✓ Record-verifiedregistrations found in 6 marketsEU SRN US-MF-000051963

This company has registrations in European Union, United States, United Kingdom, Canada, Australia, Israel — 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

10UDI-DI device records

IVD general 10

USUnited StatesFDA openFDA

192listed device types

Class I 61Class II 116Class III 7unclassified 8

plus 256 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

1registered device records

IVD general 1

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

18active device licences

Class II 9Class III 9

25 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IVD Class 2 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

pendingnot queried

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 Union10 raw hits, 0 excluded, 10 confirmed

United States256 registration records, 0 510(k), 0 PMA

United Kingdom1 confirmed, 0 excluded

Canada18 confirmed, 0 excluded

Manufacturer names merged into this page: Diagnostic Automation/ Cortez Diagnostics Inc,. · DIAGNOSTIC AUTOMATION/CORTEZ DIAGNOSTICS INC.

Regulatory identity

EU manufacturer SRN: US-MF-000051963
EU authorised representative: AR Experts B.V.
UK responsible person: Invitech Ltd

FDA listed device types

showing 8 of 192

Test, Phencyclidine (Pcp), Over The Counter 1NCI 1Enzyme Immunoassay, Phencyclidine 1Test, Syphilis, Treponemal 1Covid-19 Multi-Analyte Antigen Device 1Reagent, Coronavirus Serological 1Kit, Test, Multiple, Drugs Of Abuse, Over The Counter 1Coronavirus Antigen Detection Test System. 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	00894175000534	AccuDiag™ Ferritin ELISA	IVD general
EU	00894175000473	AccuDiag™ sTfR - Soluble Transferrin Receptor ELISA	IVD general
EU	00894175000985	AccuDiag™ Vitamin B12 ELISA	IVD general
EU	00850049545006	AccuDiag™ Folate ELISA	IVD general
UK	50568	AccuDiag	IVD general
CA	3612	MEASLES IGM ELISA	Class II
CA	3615	HSV 1 IGM ELISA	Class II
CA	3617	HSV 1 IGG ELISA	Class II

Diagnostic Automation / Cortez Diagnostics Inc.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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