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Illumina, Inc.

USA · San Diego

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 9 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

6listed device types

Class I 1Class II 4Class III 1

plus 7 registration records and 6 510(k), 34 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class II 4

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

4 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

IVD import 3

AUAustraliaTGA ARTG

8active ARTG entries

IVD Class 1 4IVD Class 2 1IVD Class 3 3

HKHong KongMDACS

3valid listings

IVD B 2IVD C 1

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

8active registrations

Class 2a 6Class 2b 2

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 States7 registration records, 6 510(k), 34 PMA, 2 excluded

Brazil4 confirmed, 0 excluded

Manufacturer names merged into this page: Illumina, Inc. · ILLUMINA, INC.

Business registration

CIK: 0001110803
Registration status: Active
Listing status: Listed (ILMN)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

22010 · K093129

42013 · K124006

FDA listed device types

Reagents For Molecular Diagnostic Test Systems 1System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection 1System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection 1High Throughput Dna Sequence Analyzer 1Dna And Rna Oncology Controls 1Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K124006	ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY	2013-11-19
US	K132750	ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY	2013-11-19
US	DEN130011	ILLUMINA MISEQDX PLATFORM	2013-11-19
BR	80839210003	NextSeq 550Dx Instrument	Class II
BR	80839210004	MiSeqDx Instrument	Class II
BR	80839210001	Instrumento NovaSeq 6000Dx	Class II

Illumina, Inc.

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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