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AFFYMETRIX, INC.

USA · Pleasanton

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Australia — 3 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

2listed device types

Class I 0Class II 2Class III 0

plus 3 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class 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

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IVD Class 1 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States3 registration records, 4 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: AFFYMETRIX, INC.

FDA 510(k) clearances by year

12004 · DEN040012

12008 · K080995

12011 · K103112

12014 · DEN130018

FDA listed device types

System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection 1Instrumentation For Clinical Multiplex Test Systems 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	DEN130018	CYTOSCAN(R) DX	2014-01-17
US	K103112	AFFYMETRIX GENE PROFILING REAGENTS	2011-05-04
US	K080995	MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM	2008-07-30
BR	10358940132	GeneChipTM System 3000Dx v.2	Class II

AFFYMETRIX, 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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