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33 device results listed.

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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

TruSight™ Oncology RNA Control

TruSight™ Oncology Controls

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020644
Basic UDI-DI: B-00816270020644
Reference: 20065042
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

Local Run Manager TruSight Oncology Comprehensive (EU) Analysis Module

TruSight™ Oncology Comprehensive (EU)

IVD generalIVDDOn the marketCompanion diagnosticsProfessional testing

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020309
Basic UDI-DI: B-00816270020309
Reference: 20051843
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: 16.07.2026 13:32

Manufacturer products Authorised representative products Authorised representative actors View details

Local Run Manager DNA GenerateFASTQ Dx Module for MiSeqDx

IVD Class ANot specifiedOn the marketProfessional testing

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020392
Basic UDI-DI: 0081627002IDPESWRF
Reference: 20063022
EMDN: -
EMDN description: GENETIC TESTS - OTHER
First on market country: -
Authorised representative: Illumina Netherlands B.V.
Last updated: 15.07.2026 22:59

Manufacturer products Authorised representative products Authorised representative actors View details

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: 15.07.2026 22:23

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: 15.07.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details

NovaSeq™ 6000Dx Library Tube

IVD Class ANot specifiedOn the marketSingle use

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020552
Basic UDI-DI: 0081627002NSQTUBECX
Reference: 20062290
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: Illumina Netherlands B.V.
Last updated: 15.07.2026 22:22

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: 15.07.2026 22:22

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: 15.07.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details

llumina® DNA Prep with Enrichment Dx with UD Indexes Set A (96 samples)

Illumina DNA Prep with Enrichment Dx Reagents

IVD Class AIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020453
Basic UDI-DI: 0081627002IDPENV
Reference: 20051352
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: Illumina Netherlands B.V.
Last updated: 15.07.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details

DRAGEN® for Illumina DNA Prep with Enrichment Dx Application for NextSeq 550Dx

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: 00816270020330
Basic UDI-DI: 0081627002IDPESWRF
Reference: 20074730
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: Illumina Netherlands B.V.
Last updated: 15.07.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details

Local Run Manager VeriSeq™ NIPT module

Local Run Manager VeriSeq NIPT module

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020255
Basic UDI-DI: 0081627002NIPTLRM95
Reference: 20044989
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: Illumina Netherlands B.V.
Last updated: 15.07.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details

VeriSeq™ NIPT Workflow Manager v2

VeriSeq NIPT Workflow Manager

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020248
Basic UDI-DI: 0081627002NIPTWFM9Q
Reference: 20044988
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Netherlands
Authorised representative: Illumina Netherlands B.V.
Last updated: 15.07.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details

VeriSeq™ NIPT v2 Assay Software

VeriSeq™ NIPT Assay Software

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020194
Basic UDI-DI: 0081627002NIPTSWXJ
Reference: 20047024
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: Illumina Netherlands B.V.
Last updated: 15.07.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details

VeriSeq™ NIPT Sample Preparation Kit (24 samples)

VeriSeq™ NIPT Sample Preparation Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020163
Basic UDI-DI: 0081627002NIPTRP
Reference: 20025895
EMDN: W0106010399
EMDN description: CHROMOSOMAL DISORDERS TESTS - OTHER
First on market country: Netherlands
Authorised representative: Illumina Netherlands B.V.
Last updated: 15.07.2026 22:22

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: 15.07.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details

TruSight™ Cystic Fibrosis Library Prep

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: 15.07.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details

NextSeq™ 550Dx Instrument

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020125
Basic UDI-DI: 0081627002NEXTSEQAD
Reference: 20005715
EMDN: W02050115
EMDN description: DNA SYNTHESIZERS
First on market country: Netherlands
Authorised representative: Illumina Netherlands B.V.
Last updated: 15.07.2026 22:22

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: 15.07.2026 22:22

Manufacturer products Authorised representative products Authorised representative actors View details