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92 device results listed.

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Cellbytes

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Cellbytes Ltd
Manufacturer SRN: FI-MF-000050442
UDI-DI: 06429830279808
Basic UDI-DI: 64298302798CBA8
Reference: CB
EMDN: W02079092
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:48

Manufacturer products View details

omnomicaNGS

omnomicsNGS

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: Euformatics Oy
Manufacturer SRN: FI-MF-000030204
UDI-DI: 06429811494008
Basic UDI-DI: 6429811494oNGSHS
Reference: 06429811494008
EMDN: W02079092
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:47

Manufacturer products View details

Agilent CytoDx Software

K1203-10000

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: Agilent Technologies, Inc.
Manufacturer SRN: US-MF-000009385
UDI-DI: 05700574037437
Basic UDI-DI: 570057R0403P3011C040700PB
Reference: K1203-10000
EMDN: W02079092
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:57

Manufacturer products Authorised representative products Authorised representative actors View details

BenchLab CNV Software

K5810AA

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: 05700574037314
Basic UDI-DI: 570057R0403P3011A040800NE
Reference: K5810AA
EMDN: W02079092
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:54

Manufacturer products Authorised representative products Authorised representative actors View details

Alissa Interpret

K5849AA

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: 05700574035631
Basic UDI-DI: 570057R0403P3011A040300MM
Reference: K5849AA
EMDN: W02079092
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:54

Manufacturer products Authorised representative products Authorised representative actors View details

GeneFoxCub

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: LaCAR MDx Technologies
Manufacturer SRN: BE-MF-000001212
UDI-DI: 05430004910121
Basic UDI-DI: 5430003908GeneFoxCubVE
Reference: GeneFoxCub
EMDN: W02079092
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:13

Manufacturer products View details

SEQUENCE Pilot

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: JSI medical systems GmbH
Manufacturer SRN: DE-MF-000033204
UDI-DI: 04262587460011
Basic UDI-DI: 426258746SP-0018Y
Reference: SP-001
EMDN: W02079092
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:43

Manufacturer products View details

Metafer

IVD Class AIVDR 2017/746On the market

Manufacturer: MetaSystems Hard & Software GmbH
Manufacturer SRN: DE-MF-000016548
UDI-DI: 04250406460014
Basic UDI-DI: 42504064METAFERF5
Reference: Metafer
EMDN: W02079092
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 00:35

Manufacturer products View details

Metafer

IVD Class AIVDR 2017/746On the market

Manufacturer: MetaSystems Hard & Software GmbH
Manufacturer SRN: DE-MF-000016548
UDI-DI: 04250406460007
Basic UDI-DI: 42504064METAFERF5
Reference: Metafer
EMDN: W02079092
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 00:31

Manufacturer products View details

Ikaros

IVD Class AIVDR 2017/746On the market

Manufacturer: MetaSystems Hard & Software GmbH
Manufacturer SRN: DE-MF-000016548
UDI-DI: 04250406450015
Basic UDI-DI: 42504064IKAROSBY
Reference: Ikaros
EMDN: W02079092
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 00:31

Manufacturer products View details

HERA

IVD Class AIVDR 2017/746On the market

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289512909
Basic UDI-DI: 42502895HERALH
Reference: HER-1000
EMDN: W02079092
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 23:57

Manufacturer products View details

eTraceLine

v11.0

IVD Class AIVDR 2017/746On the market

Manufacturer: MAK-SYSTEM Group Ltd.
Manufacturer SRN: GB-MF-000026178
UDI-DI: 03665324000067
Basic UDI-DI: 3665324eTraceLinev119F
Reference: eTraceLine (eTL)
EMDN: W02079092
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 30.07.2026 21:21

Manufacturer products Authorised representative products Authorised representative actors View details

COSMAS

v2.0

IVD Class AIVDR 2017/746On the market

Manufacturer: MAK-SYSTEM Group Ltd.
Manufacturer SRN: GB-MF-000026178
UDI-DI: 03665324000043
Basic UDI-DI: 3665324COSMASV2.024
Reference: COSMAS
EMDN: W02079092
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 30.07.2026 21:21

Manufacturer products Authorised representative products Authorised representative actors View details

ePROGESA

v5.0.3

IVD Class AIVDR 2017/746On the market

Manufacturer: MAK-SYSTEM Group Ltd.
Manufacturer SRN: GB-MF-000026178
UDI-DI: 03665324000036
Basic UDI-DI: 3665324ePROGESAv503V7
Reference: ePROGESA
EMDN: W02079092
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 30.07.2026 21:21

Manufacturer products Authorised representative products Authorised representative actors View details

T.C.S.

v1.1

IVD Class AIVDR 2017/746On the market

Manufacturer: MAK-SYSTEM Group Ltd.
Manufacturer SRN: GB-MF-000026178
UDI-DI: 03665324000029
Basic UDI-DI: 3665324TCSV1.1YE
Reference: T.C.S.
EMDN: W02079092
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 30.07.2026 21:21

Manufacturer products Authorised representative products Authorised representative actors View details

eTraceLine

v10.5

IVD Class AIVDR 2017/746On the market

Manufacturer: MAK-SYSTEM Group Ltd.
Manufacturer SRN: GB-MF-000026178
UDI-DI: 03665324000012
Basic UDI-DI: 3665324eTraceLinev1054H
Reference: eTraceLine
EMDN: W02079092
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: AR Experts B.V.
Last updated: 30.07.2026 21:21

Manufacturer products Authorised representative products Authorised representative actors View details

VIASURE V-Smart Offline

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440261148
Basic UDI-DI: 84354402MDX_VSMARTOFF5E
Reference: SPCR-SW06-CL
EMDN: W02079092
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: -
Last updated: 16.07.2026 12:19

Manufacturer products View details

80528594700008

DMSEMA SW IVDR

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: DASIT SPA
Manufacturer SRN: IT-MF-000050554
UDI-DI: 80528594700008
Basic UDI-DI: 805285947SWDMSPZ
Reference: GM11DMS01
EMDN: W02079092
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 12:04

Manufacturer products View details

HERA

IVD Class AIVDR 2017/746On the market

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289513746
Basic UDI-DI: 42502895HERALH
Reference: HER-1000
EMDN: W02079092
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 08:52

Manufacturer products View details

00860006054526

Concentriq AP-Dx

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Proscia, Inc.
Manufacturer SRN: US-MF-000027154
UDI-DI: 00860006054526
Basic UDI-DI: 0860006054526R7
Reference: Concentriq Dx
EMDN: W02079092
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Sweden
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details