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Iris Diagnostics

USA · Chatsworth

✓ Record-verifiedregistrations found in 4 markets

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

4510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

12registered devices

Class I 5Class II 7

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

5active device licences

Class II 5

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

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.

United States0 registration records, 4 510(k), 0 PMA, 11 excluded

Brazil12 confirmed, 0 excluded

Canada5 confirmed, 2 excluded

Manufacturer names merged into this page: IRIS DIAGNOSTICS, A DIVISION OF IRIS INTERNATIONAL, INC. · IRIS DIAGNOSTICS (A DIVISION OF IRIS INTERNATIONAL, INC) · IRIS DIAGNOSTICS (UMA DIVISÃO DA IRIS INTERNATIONAL, INC.) · IRIS DIAGNOSTICS

Same-named companies — This database also contains companies with near-identical names: Iris Diagnostics, A Division of Iris International, Inc., Iris International, Inc., Iris International Inc., A Division of Iris Iris I. Company name alone cannot separate their registrations, so the figures below may include either.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K171083	iChemVELOCITY Automated Urine Chemistry System	2017-05-12
US	K101185	NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY	2011-09-20
US	K091539	IQ 200 URINE ANALIZER BODY FLUIDS MODULE	2010-08-31
BR	80144950482	ANALISADORES iQ	Class II
BR	80144950485	ANALISADOR QUÍMICO DE URINA ICHEM VELOCITY	Class II
BR	80144950528	ANALISADOR QUIMICO DE URINA iChem 100	Class II
CA	68120	IQ 200 AUTOMATED URINE MICROSCOPY ANALYZER	Class II
CA	70748	URINQUICK URINE CHEMISTRY ANALYZER	Class II
CA	76631	IRISPEC CA/CB/CC URINE CHEMISTRY CONTROL	Class II

Iris Diagnostics

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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