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123 device results listed.

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Xpert®

Xpert® Check

IVD Class AIVDR 2017/746On the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940001865
Basic UDI-DI: 081164701-XPERTCHECK-3B
Reference: XPERTCHECK-CE-5
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 04:13

Manufacturer products Authorised representative products Authorised representative actors View details

Array Card Spectral Calibration Dye Kit

Array Card Kits, a part of Calibration and Verification Plates

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302000444
Basic UDI-DI: 0190302TCF0000576DAR
Reference: 4432644
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

384‑Well Region of Interest (ROI) and Background Plates

Region of Interest (ROI) and Background Plates, a part of Calibration and Verification Plates

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302000314
Basic UDI-DI: 0190302TCF0000576AAK
Reference: 4432482
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

384-Well Spectral Calibration Plate with FAM Dye

Spectral Calibration Plates, a part of Calibration and Verification Plates

IVD Class AIVDR 2017/746On the marketHuman tissuesProfessional testingSingle use

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302000284
Basic UDI-DI: 0190302TCF0000576BAM
Reference: 4432445
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

RNase P 384-Well Instrument Verification Plate

RNase P Instrument Verification Plates, a part of Calibration and Verification Plates

IVD Class AIVDR 2017/746On the marketHuman tissuesProfessional testingSingle use

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302000321
Basic UDI-DI: 0190302TCF0000576CAP
Reference: 4432500
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 22:49

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

Mic IVD Automation

Mic IVD

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Bio-Molecular Systems Pty Ltd
Manufacturer SRN: AU-MF-000025328
UDI-DI: 09357795000038
Basic UDI-DI: 93577950MicIVDG7
Reference: MIC-IVD AUTOMATION
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Türkiye
Authorised representative: mdi Europa GmbH
Last updated: 04.07.2026 00:08

Manufacturer products Authorised representative products Authorised representative actors View details

IsoAmplar

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133010471
Basic UDI-DI: 880613301047C4
Reference: FPRR043
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

08800204300010

RADIPREP

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: KH Medical Co., Ltd.
Manufacturer SRN: KR-MF-000017883
UDI-DI: 08800204300010
Basic UDI-DI: 88002043RADIPREPSD
Reference: KM001
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

TTÅniKoReader®

KM102

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: KH Medical Co., Ltd.
Manufacturer SRN: KR-MF-000017883
UDI-DI: 08800204301826
Basic UDI-DI: 880002043ImmunoequipFH
Reference: KM102
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 20:20

Manufacturer products Authorised representative products Authorised representative actors View details

ChainPro™ Real-Time Fluorescence Quantitative PCR Instrument

NGX16-4F

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsInstrumentNear-patient testingProfessional testing

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595039373
Basic UDI-DI: 868459503NGX164FYT
Reference: NGX16-4F
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 03.07.2026 18:38

Manufacturer products View details

ChainPro™ Real-Time Fluorescence Quantitative PCR Instrument

NGX8-4F

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsInstrumentNear-patient testingProfessional testing

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595032374
Basic UDI-DI: 868459503NGX84FTJ
Reference: NGX8-4F
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 03.07.2026 18:37

Manufacturer products View details

ChainPro™ Real-Time Fluorescence Quantitative PCR Instrument

NGX8-2F

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595032367
Basic UDI-DI: 868459503NGX82FTC
Reference: NGX8-2F
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 03.07.2026 18:37

Manufacturer products View details

Genomate

Genomate workstation

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Genecast (Wuhan) Precision Diagnostic Co., Ltd.
Manufacturer SRN: CN-MF-000051330
UDI-DI: 06979343850020
Basic UDI-DI: 697934385010016Z
Reference: 0100101
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 03.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

YJSeq 300 Dx Sequencing System

YJSeq 300 Dx

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shanghai YJMED BioTechnology Co., Ltd.
Manufacturer SRN: CN-MF-000055692
UDI-DI: 06977334213014
Basic UDI-DI: 697733421YJ300KJ
Reference: YJSeq 300 Dx
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 22:26

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Nucleic Acid Amplification Detection Analyzer

SmartRangerⅡ, SmartRangeⅣ, SmartRangeⅧ

IVD Class AIVDR 2017/746Not intended for EU marketInstrumentProfessional testing

Manufacturer: Nanjing RainGene Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000023111
UDI-DI: 06975178390038
Basic UDI-DI: 697517839AutoNAADAQ2
Reference: 030101CB
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 18:19

Manufacturer products Authorised representative products Authorised representative actors View details