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71 device results listed.

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05745000468119

NIFTY-2

IVD Annex II List BIVDDOn the marketProfessional testing

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468119
Basic UDI-DI: B-05745000468119
Reference: MFG02001
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Denmark
Authorised representative: -
Last updated: 02.08.2026 22:56

Manufacturer products View details

05745000468072

Oseq-gBRCA-1, Oseq-gBRCA-2

IVD generalIVDDOn the marketProfessional testing

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468072
Basic UDI-DI: B-05745000468072
Reference: MFG020003
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Denmark
Authorised representative: -
Last updated: 02.08.2026 22:56

Manufacturer products View details

05744003510085

Osmart-T-lung-1 Osmart-T-lung-2

IVD generalIVDDOn the marketProfessional testing

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05744003510085
Basic UDI-DI: B-05744003510085
Reference: /
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Denmark
Authorised representative: -
Last updated: 02.08.2026 22:55

Manufacturer products View details

AntePC

IVD generalIVDDOn the marketProfessional testing

Manufacturer: OÜ Antegenes
Manufacturer SRN: EE-MF-000028961
UDI-DI: 04745010362040
Basic UDI-DI: B-04745010362040
Reference: AntePC
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Estonia
Authorised representative: -
Last updated: 02.08.2026 14:12

Manufacturer products View details

AnteMEL

IVD generalIVDDOn the marketProfessional testing

Manufacturer: OÜ Antegenes
Manufacturer SRN: EE-MF-000028961
UDI-DI: 04745010362033
Basic UDI-DI: B-04745010362033
Reference: AnteMEL
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Estonia
Authorised representative: -
Last updated: 02.08.2026 14:12

Manufacturer products View details

AnteCRC

IVD generalIVDDOn the marketProfessional testing

Manufacturer: OÜ Antegenes
Manufacturer SRN: EE-MF-000028961
UDI-DI: 04745010362026
Basic UDI-DI: B-04745010362026
Reference: AnteCRC
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Estonia
Authorised representative: -
Last updated: 02.08.2026 14:12

Manufacturer products View details

AnteBC

AnteBC, breast cancer polygenic risk score test

IVD generalIVDDOn the marketProfessional testing

Manufacturer: OÜ Antegenes
Manufacturer SRN: EE-MF-000028961
UDI-DI: 04745010362019
Basic UDI-DI: B-04745010362019
Reference: AnteBC
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Estonia
Authorised representative: -
Last updated: 02.08.2026 14:12

Manufacturer products View details

NGSengine®

NGSengine

IVD Class CIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Genome Diagnostics B.V.
Manufacturer SRN: NL-MF-000000453
UDI-DI: 08718469360642
Basic UDI-DI: 871846936ngsengineX5
Reference: 4949940, 4949740, 4949840, 4949640
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 23:44

Manufacturer products View details

MH Guide

IVD Class CNot specifiedNo longer on the market

Manufacturer: Molecular Health GmbH
Manufacturer SRN: DE-MF-000012861
UDI-DI: 04260563550350
Basic UDI-DI: 4260563550237VS
Reference: 1000000141
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 22:55

Manufacturer products View details

MH Guide

IVD Class CNot specifiedNo longer on the market

Manufacturer: Molecular Health GmbH
Manufacturer SRN: DE-MF-000012861
UDI-DI: 04260563550343
Basic UDI-DI: 4260563550237VS
Reference: 1000000128
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 22:55

Manufacturer products View details

NanoTYPER

IVD Class CIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Omixon Biocomputing Ltd.
Manufacturer SRN: HU-MF-000003018
UDI-DI: 05999565781354
Basic UDI-DI: 599956578002TX
Reference: SW6
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:38

Manufacturer products View details

05745000468157

BGI SEQ-500

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesInstrumentKitMicrobial substancesProfessional testing

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468157
Basic UDI-DI: 5745000468BGISEQ-500PX
Reference: BGISEQ-500
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:40

Manufacturer products View details

VEGA Analysis Software

IVD Class CIVDR 2017/746On the marketCompanion diagnosticsDirect markingProfessional testing

Manufacturer: MEDICOVER GENETICS LIMITED
Manufacturer SRN: CY-MF-000009381
UDI-DI: 05298004820143
Basic UDI-DI: 52980048SFTWRUJ
Reference: Not applicable
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Cyprus
Authorised representative: -
Last updated: 31.07.2026 09:49

Manufacturer products View details

MH Guide

IVD Class CIVDR 2017/746No longer on the marketProfessional testing

Manufacturer: Molecular Health GmbH
Manufacturer SRN: DE-MF-000012861
UDI-DI: 04260563550282
Basic UDI-DI: 4260563550237VS
Reference: 1000000128
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:28

Manufacturer products View details

MH Guide

IVD Class CIVDR 2017/746No longer on the marketProfessional testing

Manufacturer: Molecular Health GmbH
Manufacturer SRN: DE-MF-000012861
UDI-DI: 04260563550275
Basic UDI-DI: 4260563550237VS
Reference: 1000000128
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:21

Manufacturer products View details

MH Guide

IVD Class CIVDR 2017/746No longer on the marketProfessional testing

Manufacturer: Molecular Health GmbH
Manufacturer SRN: DE-MF-000012861
UDI-DI: 04260563550268
Basic UDI-DI: 4260563550237VS
Reference: 1000000128
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:11

Manufacturer products View details

DISQVER

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: Noscendo GmbH
Manufacturer SRN: DE-MF-000039951
UDI-DI: 04062996000019
Basic UDI-DI: 4062996DISQVER5F
Reference: N/A
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 23:13

Manufacturer products View details

EMAG® SOFTWARE V1.4

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026635046
Basic UDI-DI: 357302BUDI002042T8
Reference: 424651
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 29.07.2026 22:53

Manufacturer products View details

SONOGEN XP

IVD generalIVDDOn the marketProfessional testing

Manufacturer: INTLAB AG
Manufacturer SRN: CH-MF-000032746
UDI-DI: D-SONOGEN_XPER
Basic UDI-DI: B-SONOGEN_XPER
Reference: n.a.
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: INTLAB Deutschland GmbH
Last updated: 23.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

50610078000366

Congenica Rare Disease

IVD generalIVDDOn the marketProfessional testing

Manufacturer: Congenica Ltd
Manufacturer SRN: GB-MF-000026168
UDI-DI: 50610078000366
Basic UDI-DI: B-50610078000366
Reference: 101
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Ireland
Authorised representative: Acorn Regulatory Consultancy Services Ltd
Last updated: 17.07.2026 02:33

Manufacturer products Authorised representative products Authorised representative actors View details