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GT NUCLEIC ACID PREP KIT

IVD Class ANot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Genomictree, Inc.
Manufacturer SRN: KR-MF-000037890
UDI-DI: 18800076500508
Basic UDI-DI: 88000765PREP1PX
Reference: GT-PREP-3
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: -
Authorised representative: KTR Europe GmbH
Last updated: 11.07.2026 12:06

Manufacturer products Authorised representative products Authorised representative actors View details

Oncomine™ Dx Target Test User Guides and Assay Definition File

Oncomine™ Dx Target Test User Guides and Assay Definition File, a part of Oncomine™ Dx Target Test

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: 10190302017763
Basic UDI-DI: B-10190302017763
Reference: A52639 (A49756)
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 11.07.2026 00:40

Manufacturer products Authorised representative products Authorised representative actors View details

InfectID-Client Software

V1.1

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: Microbio Ltd
Manufacturer SRN: AU-MF-000033903
UDI-DI: 09309001216023
Basic UDI-DI: B-09309001216023
Reference: V1.1
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Czechia
Authorised representative: Qualrep Services B.V.
Last updated: 10.07.2026 22:37

Manufacturer products Authorised representative products Authorised representative actors View details

Illumina DRAGEN® Server for NextSeq550Dx

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020811
Basic UDI-DI: 0081627002NEXTSEQAD
Reference: 20086130
EMDN: W02050115
EMDN description: DNA SYNTHESIZERS
First on market country: -
Authorised representative: Illumina Netherlands B.V.
Last updated: 09.07.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa ST401i

IVD Class ANot specifiedOn the marketDirect markingInstrumentKitReagent

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013950069
Basic UDI-DI: 888501395SSQ301P2E
Reference: 400124
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: -
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 08.07.2026 10:19

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa ST401e

IVD Class ANot specifiedOn the marketDirect markingInstrumentKitReagent

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013950076
Basic UDI-DI: 888501395SSQ301P2E
Reference: 400120
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: -
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 08.07.2026 10:19

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa ST Template Kit (8)

IVD Class ANot specifiedOn the marketDirect markingInstrumentKitReagent

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013956207
Basic UDI-DI: 888501395SSQ301P2E
Reference: 690006
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: -
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 08.07.2026 10:19

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SQ Sequencing Kit (8)

IVD Class ANot specifiedOn the marketDirect markingInstrumentKitReagent

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013956252
Basic UDI-DI: 888501395SSQ301P2E
Reference: 690004
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: -
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 08.07.2026 10:19

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SQ 318 Chip Kit (8)

IVD Class ANot specifiedOn the marketDirect markingInstrumentKitReagent

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013956290
Basic UDI-DI: 888501395SSQ301P2E
Reference: 300302
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: -
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 08.07.2026 10:19

Manufacturer products Authorised representative products Authorised representative actors View details

Genesystems© Genebytes

IVD generalIVDDOn the marketProfessional testing

Manufacturer: SISTEMAS GENOMICOS. S.L.
Manufacturer SRN: ES-MF-000022949
UDI-DI: 08436566763219
Basic UDI-DI: B-08436566763219
Reference: LV4827
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:47

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Genesystems© – G-PRECON

IVD generalIVDDOn the market

Manufacturer: SISTEMAS GENOMICOS. S.L.
Manufacturer SRN: ES-MF-000022949
UDI-DI: 08436566763202
Basic UDI-DI: B-08436566763202
Reference: LV4826
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:47

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Genesystems G-NIPT

Genesystems© G-NIPT

IVD Annex II List BIVDDOn the marketProfessional testing

Manufacturer: SISTEMAS GENOMICOS. S.L.
Manufacturer SRN: ES-MF-000022949
UDI-DI: 08436566763196
Basic UDI-DI: B-08436566763196
Reference: LV4825
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:47

Manufacturer products View details

DTstream 9L4