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AutoMated Nucleic Acid Extraction System

GeneX E6, GeneX E6s

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802605622
Basic UDI-DI: 69268026GeneXE600000001P2
Reference: GeneX E6
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 31.07.2026 18:41

Manufacturer products Authorised representative products Authorised representative actors View details

Real-Time PCR System Lepgen-96

Lepgen-96

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentKitProfessional testing

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807600948
Basic UDI-DI: 692180760094FA
Reference: JY18Lepgen-96
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 31.07.2026 18:11

Manufacturer products Authorised representative products Authorised representative actors View details

Promotor 960 Real-Time PCR System

RTQ-960

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Acon Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000006977
UDI-DI: 06921756498122
Basic UDI-DI: 6921756499990012WU
Reference: P111-2011-201
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 18:11

Manufacturer products Authorised representative products Authorised representative actors View details

GenomEra CDX System

CDX-10

IVD Class AIVDR 2017/746No longer on the marketInstrumentProfessional testing

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: 06438556100204
Basic UDI-DI: 6438556CDX-10RB
Reference: CDX-10-020
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:55

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

BGI

SI-POCT-02

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: 05745000468355
Basic UDI-DI: 5745000468EU02000400019E
Reference: EU0200040001
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Denmark
Authorised representative: -
Last updated: 31.07.2026 12:40

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

MagnisDx NGS Prep System

K1007A

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: 05700574036850
Basic UDI-DI: 570057R0802P3011A040500SJ
Reference: K1007A
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
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

AriaDx Real-Time PCR Instrument

K8930A

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: 05700574036843
Basic UDI-DI: 570057R0802P3011A040400SD
Reference: K8930A
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
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

SureScan Dx Microarray Scanner

G5761A

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Agilent Technologies Singapore (International) Pte Ltd
Manufacturer SRN: SG-MF-000014448
UDI-DI: 05700571108703
Basic UDI-DI: 570057R0802P3011A040200S3
Reference: G5761A
EMDN: W02050299
EMDN description: MICRO-ARRAY INSTRUMENTS - OTHER
First on market country: Denmark
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 31.07.2026 11:50

Manufacturer products Authorised representative products Authorised representative actors View details

Idylla™ Hub

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biocartis NV
Manufacturer SRN: BE-MF-000003661
UDI-DI: 05415219001390
Basic UDI-DI: 5415219P1030H2
Reference: P1030
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:53

Manufacturer products View details

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

Idylla™ Console

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biocartis NV
Manufacturer SRN: BE-MF-000003661
UDI-DI: 05415219000126
Basic UDI-DI: 5415219P1010GU
Reference: P1010
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:53

Manufacturer products View details

Idylla™ Instrument

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biocartis NV
Manufacturer SRN: BE-MF-000003661
UDI-DI: 05415219000119
Basic UDI-DI: 5415219P0010GM
Reference: P0010
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:53

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

PEBBLE qcLAMP Platform

Pebble qcLAMP Platform

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

Manufacturer: BIOPIX DNA TECHNOLOGY P.C.
Manufacturer SRN: GR-MF-000033590
UDI-DI: 05210166000027
Basic UDI-DI: 5210166000057M3
Reference: 000057
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Greece
Authorised representative: -
Last updated: 31.07.2026 09:45

Manufacturer products View details

Benchbot® 4800

4800

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: EntroGen, Inc.
Manufacturer SRN: US-MF-000022721
UDI-DI: 05060536830750
Basic UDI-DI: 506053683BBOT01ZU
Reference: BBOT4800
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Italy
Authorised representative: TANJA TOPOVSEK S.P.
Last updated: 31.07.2026 08:48

Manufacturer products Authorised representative products Authorised representative actors View details

Randox Discovery

IVD Class AIVDR 2017/746On the marketNo EU repDirect markingInstrumentProfessional testing

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273216943
Basic UDI-DI: 50552732ADISCOV018FH
Reference: RDC10000
EMDN: W02050201
EMDN description: MICRO-ARRAY ANALYSERS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:12

Manufacturer products View details

geneLEAD VIII

geneLEAD

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Precision System Science Co., Ltd.
Manufacturer SRN: JP-MF-000029061
UDI-DI: 04987869127009
Basic UDI-DI: 4987869geneLEAD8S
Reference: A2700
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Sweden
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:43

Manufacturer products Authorised representative products Authorised representative actors View details

geneLEAD XXIV

geneLEAD

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Precision System Science Co., Ltd.
Manufacturer SRN: JP-MF-000029061
UDI-DI: 04987869122400
Basic UDI-DI: 4987869geneLEAD24UE
Reference: A2240
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:43

Manufacturer products Authorised representative products Authorised representative actors View details