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DELBIO Automated Nucleic Acid Analysis System

Automated Nucleic Acid Analysis System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: DELBIO INC.
Manufacturer SRN: TW-MF-000003400
UDI-DI: 04713072985019
Basic UDI-DI: 471307298G1QT
Reference: G1-01
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 06:29

Manufacturer products Authorised representative products Authorised representative actors View details

DTprime II 4M1

DTprime II

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014366453
Basic UDI-DI: 466001436DA04ZS
Reference: О-DTPRIMEII4M1-EU
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 06:20

Manufacturer products Authorised representative products Authorised representative actors View details

DTstream 9L1

DTstream

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: DNA-Technology, Research & Production, LLC
Manufacturer SRN: RU-MF-000028223
UDI-DI: 04660014366323
Basic UDI-DI: 466001436DA03ZQ
Reference: O-DTstream9L1-A-EU
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 06:20

Manufacturer products Authorised representative products Authorised representative actors View details

Automated TRCR Real-time Monitor TRCReady-80

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04562185395259
Basic UDI-DI: 45601892100040037K
Reference: 0023950
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 31.07.2026 06:01

Manufacturer products Authorised representative products Authorised representative actors 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

NovaSeq™ 6000Dx Instrument

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Illumina, Inc.
Manufacturer SRN: US-MF-000013476
UDI-DI: 00816270020637
Basic UDI-DI: 0081627002NSQX2
Reference: 20068232
EMDN: W02050115
EMDN description: DNA SYNTHESIZERS
First on market country: Netherlands
Authorised representative: Illumina Netherlands B.V.
Last updated: 30.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

NUCLISENS® easyMAG® Disposables

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026616618
Basic UDI-DI: 357302BUDI000508TK
Reference: 542632
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:55

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

FilmArray® 2.0 Instrument

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BioFire Diagnostics, LLC
Manufacturer SRN: US-MF-000003311
UDI-DI: 00815381020031
Basic UDI-DI: 357302BUDI000020SG
Reference: FLM2-ASY-0001
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 30.07.2026 02:34

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDxTM 200

WonDx-1001, WonDx-1002, WonDx-1003, WonDx-1004, WonDx-1005, WonDx-1006, WonDx-1007, WonDx-1008, U-CardDx 200-1001, U-CardDx 200-1002, U-CardDx 200-1003, U-CardDx 200-1004,U-CardDx 200-1005,U-CardDx 200-1006, U-CardDx 200-1007,U-CardDx 200-1008

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850506
Basic UDI-DI: 69332898CE3186FW
Reference: WK46
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 29.07.2026 23:07

Manufacturer products Authorised representative products Authorised representative actors 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

SpotFire®

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

Manufacturer: BioFire Diagnostics, LLC
Manufacturer SRN: US-MF-000003311
UDI-DI: 00815381020369
Basic UDI-DI: 357302BUDI000917U8
Reference: FAST-ASY-0002
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 29.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDxTM 200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850513
Basic UDI-DI: 69332898CE3186FW
Reference: WK47
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 29.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDxTM 200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850520
Basic UDI-DI: 69332898CE3186FW
Reference: WK48
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 29.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDxTM 200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850537
Basic UDI-DI: 69332898CE3186FW
Reference: WK49
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 29.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

QIAsymphony Connect

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: QIAGEN GmbH
Manufacturer SRN: DE-MF-000004949
UDI-DI: 04053228049982
Basic UDI-DI: 4053228IQSC000000000001MF
Reference: 9003450
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: -
Last updated: 29.07.2026 09:33

Manufacturer products View details

GINA 500

IVD Class ANot specifiedOn the marketKitProfessional testingReagentSingle use

Manufacturer: Cube Dx GmbH
Manufacturer SRN: AT-MF-000013909
UDI-DI: 09120127730244
Basic UDI-DI: 912012773GINA7H
Reference: 09120127730244
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: -
Authorised representative: -
Last updated: 26.07.2026 18:08

Manufacturer products View details