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26 device results listed.

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Idylla™ Console Software Plus (CSW+)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biocartis NV
Manufacturer SRN: BE-MF-000003661
UDI-DI: 05415219001178
Basic UDI-DI: 5415219P2040HC
Reference: P2040
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:53

Manufacturer products View details

Diomni™ Software V4.3.1

Diomni™ Software

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302020046
Basic UDI-DI: 0190302TCF00005384V
Reference: A40007355
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: 30.07.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

Alinity m

ALINITY M HIV-1 DBS ASF

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Abbott Molecular Inc.
Manufacturer SRN: US-MF-000017776
UDI-DI: 00884999051645
Basic UDI-DI: 0884999AMN0053WH
Reference: 08N45-04B
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: Abbott GmbH
Last updated: 16.07.2026 07:24

Manufacturer products Authorised representative products Authorised representative actors View details

VIPER

BD Viper LT system software

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Becton, Dickinson and Company
Manufacturer SRN: US-MF-000018910
UDI-DI: 00382904429485
Basic UDI-DI: 038290HGAGGXEJZL
Reference: 442948
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Becton Dickinson Ireland Limited
Last updated: 15.07.2026 23:34

Manufacturer products Authorised representative products Authorised representative actors View details

Oncomine™ Dx Target Test User Guides and Assay Definition File

A54452

IVD Class CIVDR 2017/746On the marketCompanion diagnosticsProfessional testing

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: 10190302018333
Basic UDI-DI: 0190302A54452SE
Reference: A54452 (A65538)
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: 15.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Diomni™ Software V3.1.0

Diomni™ Software

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302018135
Basic UDI-DI: 0190302TCF00005384V
Reference: A54762 (A56307)
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: 15.07.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

BGI

knowliter-1

IVD generalIVDDOn the marketProfessional testing

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-knowliter-1KS
Basic UDI-DI: B-knowliter-1KS
Reference: knowliter-1
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 14:20

Manufacturer products View details

Oncomine™ Dx Express Test - Plasma - v2.1.0 ADF

Oncomine™ Dx Express Test - Plasma - v2.1.0 ADF, a part of Ion Torrent™ Oncomine™ Dx Express Test

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: D-USMF000023929A40010738W
Basic UDI-DI: B-USMF000023929A40010738W
Reference: A40010734
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: 15.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

Oncomine™ Dx Express Test - FFPE - v2.1.0 ADF

Oncomine™ Dx Express Test - FFPE - v2.1.0 ADF, a part of Ion Torrent™ Oncomine™ Dx Express Test

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Life Technologies Corporation
Manufacturer SRN: US-MF-000023929
UDI-DI: D-USMF000023929A40004679G
Basic UDI-DI: B-USMF000023929A40004679G
Reference: A40004674
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: 15.07.2026 11:47

Manufacturer products Authorised representative products Authorised representative actors View details

BGI

SIGVAR

IVD generalIVDDOn the marketProfessional testing

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SIGVARNZ
Basic UDI-DI: B-SIGVARNZ
Reference: SIGVAR
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 06:29

Manufacturer products 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

80575074300470

bAPP

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hyris Srl
Manufacturer SRN: IT-MF-000031635
UDI-DI: 80575074300470
Basic UDI-DI: 805750743BAPPDK
Reference: bAPP
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:48

Manufacturer products View details

SOPHiA DDM Dx mode

IVD Class AIVDR 2017/746On the marketDirect marking

Manufacturer: SOPHiA GENETICS SA
Manufacturer SRN: CH-MF-000025221
UDI-DI: 07622283009681
Basic UDI-DI: 762228300110AE
Reference: DXMode
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: France
Authorised representative: SOPHiA GENETICS SAS
Last updated: 03.07.2026 06:08

Manufacturer products Authorised representative products Authorised representative actors View details

Eonis EASI

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147402670
Basic UDI-DI: 6438147EonisEASI_88
Reference: 2044-3010
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

04049095260674

RIDA®SEEK

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095260674
Basic UDI-DI: 4049095ZRIDASEEK0FN
Reference: ZRIDASEEK
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:53

Manufacturer products View details

Analyzer GENERIC HBV VL 2.0 FCXT

Analyzer

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003945
Basic UDI-DI: 40490550300001109UE
Reference: 1901991
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:48

Manufacturer products View details

WorklistGenerator

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003808
Basic UDI-DI: 40490550300001088UX
Reference: 1896936
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 18:48

Manufacturer products View details

Diomni™ Software V4.0.0

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302019408
Basic UDI-DI: 0190302TCF00005384V
Reference: A58343 (A58195, A58341)
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: Life Technologies Europe B.V.
Last updated: 29.06.2026 10:50

Manufacturer products Authorised representative products Authorised representative actors View details

Diomni™ Software V4.1.0

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302019514
Basic UDI-DI: 0190302TCF00005384V
Reference: A59789 (A58195, A58341)
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: Life Technologies Europe B.V.
Last updated: 29.06.2026 10:50

Manufacturer products Authorised representative products Authorised representative actors View details

Diomni™ Software V4.2.0

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Life Technologies Holdings Pte Ltd
Manufacturer SRN: SG-MF-000023931
UDI-DI: 10190302019859
Basic UDI-DI: 0190302TCF00005384V
Reference: A40002323
EMDN: W02050182
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES
First on market country: -
Authorised representative: Life Technologies Europe B.V.
Last updated: 29.06.2026 10:50

Manufacturer products Authorised representative products Authorised representative actors View details