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98 device results listed.

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Concentriq AP-Dx

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Proscia, Inc.
Manufacturer SRN: US-MF-000027154
UDI-DI: 00850070164016
Basic UDI-DI: 0860006054526R7
Reference: DX050GL
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: 21.09.2026 21:14

Manufacturer products Authorised representative products Authorised representative actors View details

06955792735927

Analysis Software for Novel Coronavirus Genom

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735927
Basic UDI-DI: B-06955792735927
Reference: San-ncov-Seq
EMDN: W02079092
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:10

Manufacturer products Authorised representative products Authorised representative actors View details

06955792735910

Analysis Software for BRCA Gene Genetic Variants

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735910
Basic UDI-DI: B-06955792735910
Reference: Sa_BGT
EMDN: W02079092
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:10

Manufacturer products Authorised representative products Authorised representative actors View details

06955792735903

Analysis Software for PCR-Fluorescence Detection Data

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735903
Basic UDI-DI: B-06955792735903
Reference: PCRAnalyzer-100
EMDN: W02079092
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:10

Manufacturer products Authorised representative products Authorised representative actors View details

My+

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Mylab Oy
Manufacturer SRN: FI-MF-000048232
UDI-DI: 06429830135913
Basic UDI-DI: B-06429830135913
Reference: Not applicable
EMDN: W02079092
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:55

Manufacturer products View details

My+ verikeskus

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Mylab Oy
Manufacturer SRN: FI-MF-000048232
UDI-DI: 06429830135906
Basic UDI-DI: B-06429830135906
Reference: Not applicable
EMDN: W02079092
EMDN description: VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Finland
Authorised representative: -
Last updated: 03.08.2026 03:55

Manufacturer products View details

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