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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

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

OI-genomic profiling assay

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: Laboratory Corporation of America Holdings
Manufacturer SRN: US-MF-000017722
UDI-DI: D-US-MF-000017722U2
Basic UDI-DI: B-US-MF-000017722U2
Reference: OI-GPA
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Austria
Authorised representative: European Healthcare & Device Solutions Ltd.
Last updated: 15.07.2026 11:34

Manufacturer products Authorised representative products Authorised representative actors View details

DNA in situ Hybridization Reagents

Sub telomere Probes(

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: CytoTest Inc.
Manufacturer SRN: US-MF-000054699
UDI-DI: D-STP-xxxQP
Basic UDI-DI: B-STP-xxxQP
Reference: STP-xxx
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 15.07.2026 10:45

Manufacturer products Authorised representative products Authorised representative actors View details

Universal Sequencing Reaction Kit T1+ FCL SE50

IVD Class ANot specifiedOn the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Shenzhen MGI Biological Electronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044825
UDI-DI: 06975996270376
Basic UDI-DI: 697599627S-Kit35
Reference: 940-002752-00
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

Universal Sequencing Reaction Kit T1+ FCL SE50

IVD Class ANot specifiedOn the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Shenzhen MGI Biological Electronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044825
UDI-DI: 06975996270321
Basic UDI-DI: 697599627S-Kit35
Reference: 940-002752-00
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

Universal Sequencing Reaction Kit T1+ App-D FCL PE150

IVD Class ANot specifiedOn the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Shenzhen MGI Biological Electronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044825
UDI-DI: 06975996270383
Basic UDI-DI: 697599627S-Kit35
Reference: 940-002751-00
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

Universal Sequencing Reaction Kit T1+ App-D FCL PE150

IVD Class ANot specifiedOn the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Shenzhen MGI Biological Electronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044825
UDI-DI: 06975996270314
Basic UDI-DI: 697599627S-Kit35
Reference: 940-002751-00
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

Universal Sequencing Reaction Kit T1+ App-D FCL SE100

IVD Class ANot specifiedOn the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Shenzhen MGI Biological Electronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044825
UDI-DI: 06975996270390
Basic UDI-DI: 697599627S-Kit35
Reference: 940-002765-00
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

Universal Sequencing Reaction Kit T1+ App-D FCL SE100

IVD Class ANot specifiedOn the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Shenzhen MGI Biological Electronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044825
UDI-DI: 06975996270307
Basic UDI-DI: 697599627S-Kit35
Reference: 940-002765-00
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

Universal Sequencing Reaction Kit T1+ App-D FCL SE50

IVD Class ANot specifiedOn the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Shenzhen MGI Biological Electronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044825
UDI-DI: 06975996270406
Basic UDI-DI: 697599627S-Kit35
Reference: 940-002768-00
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

Universal Sequencing Reaction Kit T1+ FCL SE100

IVD Class ANot specifiedOn the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Shenzhen MGI Biological Electronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044825
UDI-DI: 06975996270338
Basic UDI-DI: 697599627S-Kit35
Reference: 940-002764-00
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

beREADY test

READY-2

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Celvia CC AS
Manufacturer SRN: EE-MF-000045569
UDI-DI: D-READY17660AB
Basic UDI-DI: B-READY17660AB
Reference: beREADY test
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Estonia
Authorised representative: -
Last updated: 15.07.2026 05:26

Manufacturer products View details

GENEDIAN

Cervical Cancer Methylation Test

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Hangzhou DIAN Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000007252
UDI-DI: D-RA013UJ
Basic UDI-DI: B-RA013UJ
Reference: P122-07048
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 05:25

Manufacturer products Authorised representative products Authorised representative actors View details

08033629924602

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Nuclear Laser Medicine srl
Manufacturer SRN: IT-MF-000025709
UDI-DI: 08033629924602
Basic UDI-DI: 803362992PHARMAGENPLUSFB
Reference: FA187/10
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 14.07.2026 22:55

Manufacturer products View details

Universal Sequencing Reaction Kit T1+ FCL PE150

IVD Class ANot specifiedOn the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Shenzhen MGI Biological Electronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044825
UDI-DI: 06975996270352
Basic UDI-DI: 697599627S-Kit35
Reference: 940-002760-00
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

Universal Sequencing Reaction Kit T1+ FCL PE150

IVD Class ANot specifiedOn the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Shenzhen MGI Biological Electronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044825
UDI-DI: 06975996270345
Basic UDI-DI: 697599627S-Kit35
Reference: 940-002760-00
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details