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38 device results listed.

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TruSight™ Oncology Comprehensive (DRAGEN)

IVD Class CIVDR 2017/746On the marketCompanion diagnosticsHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020934
Basic UDI-DI: 0081627002TSODGTX
Reference: 20140799
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: Illumina Netherlands B.V.
Last updated: 04.08.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details

TruSight™ Oncology Comprehensive HRD (DRAGEN)

IVD Class CIVDR 2017/746On the marketCompanion diagnosticsHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020927
Basic UDI-DI: 0081627002TSOHRDDGRK
Reference: 20134650
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: Illumina Netherlands B.V.
Last updated: 04.08.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details

Illumina Connected Run TruSight™ Oncology Comprehensive HRD (EU, DRAGEN) Analysis Module

IVD Class CIVDR 2017/746On the marketCompanion diagnosticsProfessional testing

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020897
Basic UDI-DI: 0081627002ICRTSOHRD6B
Reference: 20132935
EMDN: W01060299
EMDN description: TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
First on market country: Netherlands
Authorised representative: Illumina Netherlands B.V.
Last updated: 04.08.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details

TruSight™ Oncology RNA Control v2

TruSight™ Oncology Controls v2

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020866
Basic UDI-DI: 0081627002RNADNACTRLMV
Reference: 20090165
EMDN: W0101050102
EMDN description: UNASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Netherlands
Authorised representative: Illumina Netherlands B.V.
Last updated: 04.08.2026 20:56

Manufacturer products Authorised representative products Authorised representative actors View details

TruSight™ Oncology DNA Control v2

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020873
Basic UDI-DI: 0081627002RNADNACTRLMV
Reference: 20090155
EMDN: W0101050102
EMDN description: UNASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: -
Authorised representative: Illumina Netherlands B.V.
Last updated: 03.08.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

VeriSeq™ NIPT Sample Prep Kit (96 samples)

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020187
Basic UDI-DI: 0081627002NIPTRP
Reference: 15066802
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: Illumina Netherlands B.V.
Last updated: 03.08.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

VeriSeq™ NIPT Sample Preparation Kit (48 samples)

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020170
Basic UDI-DI: 0081627002NIPTRP
Reference: 15066801
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: -
Authorised representative: Illumina Netherlands B.V.
Last updated: 03.08.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

TruSight™ Cystic Fibrosis

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020149
Basic UDI-DI: 0081627002CYSTFIB8C
Reference: 20036925
EMDN: W0106010101
EMDN description: CYSTIC FIBROSIS
First on market country: Netherlands
Authorised representative: Illumina Netherlands B.V.
Last updated: 03.08.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

MiSeq™Dx Reagent Kit v3

MiSeq™Dx Reagent Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020156
Basic UDI-DI: 0081627002KITV3PX
Reference: 20037124
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: Illumina Netherlands B.V.
Last updated: 30.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

MiSeq™Dx Reagent Kit v3 Micro

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020668
Basic UDI-DI: 0081627002KITV3PX
Reference: 20063860
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: -
Authorised representative: Illumina Netherlands B.V.
Last updated: 30.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

NextSeq™ 550Dx High Output Reagent Kit v2.5 (300 cycles)

NextSeq™ 550Dx High Output Reagent Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020118
Basic UDI-DI: 0081627002HOKTQU
Reference: 20028871
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: Illumina Netherlands B.V.
Last updated: 30.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 cycles)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020132
Basic UDI-DI: 0081627002HOKTQU
Reference: 20028870
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: -
Authorised representative: Illumina Netherlands B.V.
Last updated: 30.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

NovaSeq™ 6000Dx Instrument

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020637
Basic UDI-DI: 0081627002NSQX2
Reference: 20068232
EMDN: W02050115
EMDN description: DNA SYNTHESIZERS
First on market country: Netherlands
Authorised representative: Illumina Netherlands B.V.
Last updated: 30.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

NovaSeq 6000Dx S2 Reagent v1.5 Kit (300 cycles)

NovaSeq™ 6000Dx Reagent v1.5 Kit (300 cycles)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020538
Basic UDI-DI: 0081627002NSQKTTN
Reference: 20046931
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: Illumina Netherlands B.V.
Last updated: 30.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

NovaSeq™ 6000Dx S4 Reagent v1.5 Kit (300 cycles)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020569
Basic UDI-DI: 0081627002NSQKTTN
Reference: 20046933
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: -
Authorised representative: Illumina Netherlands B.V.
Last updated: 30.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

NovaSeq™ 6000Dx S2 Buffer Cartridge

NovaSeq™ 6000Dx Buffer Cartridge

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020545
Basic UDI-DI: 0081627002NSQBUFXH
Reference: 20062292
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: Illumina Netherlands B.V.
Last updated: 30.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

iScan™Dx

iScanDx

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020682
Basic UDI-DI: 0081627002iScan89
Reference: 20081314
EMDN: W02050201
EMDN description: MICRO-ARRAY ANALYSERS
First on market country: Netherlands
Authorised representative: Illumina Netherlands B.V.
Last updated: 30.07.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

Local Run Manager DNA GenerateFASTQ Dx Module for MiSeqDx

Illumina® DNA Prep with Enrichment Dx Software

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020392
Basic UDI-DI: 0081627002IDPESWRF
Reference: 20063022
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: Illumina Netherlands B.V.
Last updated: 30.07.2026 18:24

Manufacturer products Authorised representative products Authorised representative actors View details

NovaSeq™ 6000Dx Library Tubes, 24 Pk

NovaSeq™ 6000Dx Library Tube

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020583
Basic UDI-DI: 0081627002NSQTUBECX
Reference: 20062291
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: Illumina Netherlands B.V.
Last updated: 22.07.2026 03:18

Manufacturer products Authorised representative products Authorised representative actors View details

TruSight™ Oncology DNA Control

TruSight™ Oncology Controls

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020651
Basic UDI-DI: B-00816270020651
Reference: 20065041
EMDN: W0101050102
EMDN description: UNASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Netherlands
Authorised representative: Illumina Netherlands B.V.
Last updated: 16.07.2026 13:32

Manufacturer products Authorised representative products Authorised representative actors View details