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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

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

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

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

magLEAD 4gC

magLEAD

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentProfessional testing

Manufacturer: Precision System Science Co., Ltd.
Manufacturer SRN: JP-MF-000029061
UDI-DI: 04987869111404
Basic UDI-DI: 4987869magLEAD4gCFK
Reference: A1140
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
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

magLEAD 12gC LiNK(Abalat)

magLEAD

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentProfessional testing

Manufacturer: Precision System Science Co., Ltd.
Manufacturer SRN: JP-MF-000029061
UDI-DI: 04987869111329
Basic UDI-DI: 4987869magLEAD12gCLiNKKM
Reference: A1132
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:43

Manufacturer products Authorised representative products Authorised representative actors View details

magLEAD 12gC

magLEAD

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Precision System Science Co., Ltd.
Manufacturer SRN: JP-MF-000029061
UDI-DI: 04987869111206
Basic UDI-DI: 4987869magLEADHX
Reference: A1120
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
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

RD-210

Gene Amplification Detector

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562470648
Basic UDI-DI: 4987562RD-210UM
Reference: CP437283
EMDN: W02050180
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 07:35

Manufacturer products Authorised representative products Authorised representative actors View details

04987562412730

LYNORHAG

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562412730
Basic UDI-DI: 4987562LYNORHAGZ2
Reference: CL-485-270
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

04899959024511

Real-Time qPCR System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: QUANTIDX HONG KONG LIMITED
Manufacturer SRN: HK-MF-000023647
UDI-DI: 04899959024511
Basic UDI-DI: 489995902451SL
Reference: SimpiDx Q16
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 31.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

04897036920022

92002

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DiagCor Life Science Limited
Manufacturer SRN: HK-MF-000045806
UDI-DI: 04897036920022
Basic UDI-DI: 489703692920024F
Reference: 92002
EMDN: W02050101
EMDN description: NUCLEIC ACID HYBRIDIZATION UNITS
First on market country: Bulgaria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 07:13

Manufacturer products Authorised representative products Authorised representative actors View details

MagCore® Super Automated Nucleic Acid Extractor

MagCore® System

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testingReagent

Manufacturer: RBCBioscience Corp.
Manufacturer SRN: TW-MF-000026757
UDI-DI: 04719890670021
Basic UDI-DI: 471989067M0000A9
Reference: MCA1602
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 07:01

Manufacturer products Authorised representative products Authorised representative actors View details

Genetic Sequencer DNBSEQ-G400

DNBSEQ-G400, DNBSEQ-G99, DNBSEQ-G99A

IVD Class AIVDR 2017/746On the marketDirect marking

Manufacturer: Latvia MGI Tech
Manufacturer SRN: LV-MF-000017790
UDI-DI: 04751041380014
Basic UDI-DI: 475104138SEQHH
Reference: 900-000492-00
EMDN: W02050108
EMDN description: GENETIC SYSTEM READERS
First on market country: Latvia
Authorised representative: -
Last updated: 31.07.2026 06:58

Manufacturer products View details

MagCore® Compact Automated Nucleic Acid Extractor

MagCore® System

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testingReagent

Manufacturer: RBCBioscience Corp.
Manufacturer SRN: TW-MF-000026757
UDI-DI: 04719890670014
Basic UDI-DI: 471989067M0000A9
Reference: MCA0801
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

MagCore® HF16 Automated Nucleic Acid Extractor

MagCore® System

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testingReagent

Manufacturer: RBCBioscience Corp.
Manufacturer SRN: TW-MF-000026757
UDI-DI: 04719890670007
Basic UDI-DI: 471989067M0000A9
Reference: MCA1601
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 31.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

Katsura Biological Coporation

A-20-M03201

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Katsura Biological Corp
Manufacturer SRN: TW-MF-000044228
UDI-DI: 04719883180322
Basic UDI-DI: 471988318M32N8
Reference: M32
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Italy
Authorised representative: Kingsmead Service B.V.
Last updated: 31.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

Katsura Biological Coporation

S2R16B

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Katsura Biological Corp
Manufacturer SRN: TW-MF-000044228
UDI-DI: 04719883180018
Basic UDI-DI: 471988318S2R16BGB
Reference: S2R16B
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: Kingsmead Service B.V.
Last updated: 31.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details