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97 device results listed.

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Real-time Fluorescence Quantitative PCR lnstrument

OPqPCR1600

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagentSelf testing

Manufacturer: Wuxi Opulen Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023008
UDI-DI: 06975061571612
Basic UDI-DI: 697506157OPqPCR1600BL
Reference: N/A
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:59

Manufacturer products Authorised representative products Authorised representative actors View details

Real time fluorescence quantitative PCR Device

OP-qPCR1600C

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Wuxi Opulen Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023008
UDI-DI: 06975061571605
Basic UDI-DI: 697506157OPqPCR1600C65
Reference: 1722023
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Germany
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 17:59

Manufacturer products Authorised representative products Authorised representative actors View details

All-in-one Digital PCR Device

DQ24-Dx

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Suzhou Sniper Medical Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000017448
UDI-DI: 06974944990007
Basic UDI-DI: 697494499000RD
Reference: DQ24-Dx
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 17:46

Manufacturer products Authorised representative products Authorised representative actors View details

06974884777904

Genesy

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Xi'an Tianlong Science and Technology Co., Ltd.
Manufacturer SRN: CN-MF-000001079
UDI-DI: 06974884777904
Basic UDI-DI: 697488477TLH003YT
Reference: Y007H
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:39

Manufacturer products Authorised representative products Authorised representative actors View details

06974884777638

PANA 9600S, PANA 9600X, PANA 3200S, PANA 3200S+

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Xi'an Tianlong Science and Technology Co., Ltd.
Manufacturer SRN: CN-MF-000001079
UDI-DI: 06974884777638
Basic UDI-DI: 697488477TLH004YV
Reference: Y064H
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:39

Manufacturer products Authorised representative products Authorised representative actors View details

06974884777560

Aurora PANA X6

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Xi'an Tianlong Science and Technology Co., Ltd.
Manufacturer SRN: CN-MF-000001079
UDI-DI: 06974884777560
Basic UDI-DI: 697488477TLH017Z6
Reference: Y068H
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:39

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Extraction System

Libex, GeneRotex 24, GeneRotex 48, GeneRotex 96, GeneFlex 16, GeneFlex 32, GeneFlex 48, GeneFlex 96, GeneFlex 192, Npex 192, PowerEXP™ 32

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Xi'an Tianlong Science and Technology Co., Ltd.
Manufacturer SRN: CN-MF-000001079
UDI-DI: 06974884776327
Basic UDI-DI: 697488477TLH002YR
Reference: Y005H-KG-01
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:39

Manufacturer products Authorised representative products Authorised representative actors View details

06974884776310

Gentier 48E, Gentier 48R, Gentier 96E, Gentier 96T, Gentier 96R, Gentier Mini, Gentier mini+, Gentier X3E, Gentier X3R, Gentier X3S, Gentier X3C, FLUORITE, PowerAmp96™ Dx

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Xi'an Tianlong Science and Technology Co., Ltd.
Manufacturer SRN: CN-MF-000001079
UDI-DI: 06974884776310
Basic UDI-DI: 697488477TLH001YP
Reference: Y034H-KG-01
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:39

Manufacturer products Authorised representative products Authorised representative actors View details

06974884776334

Gentier Sp96E, Gentier Sp96R, Gentier Sp96X, Gentier Sp96V, Gentier Sp384E, Gentier Sp384R

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Xi'an Tianlong Science and Technology Co., Ltd.
Manufacturer SRN: CN-MF-000001079
UDI-DI: 06974884776334
Basic UDI-DI: 697488477TLH015Z2
Reference: TL59BRH
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:39

Manufacturer products Authorised representative products Authorised representative actors View details

06974884776198

Npex 96

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Xi'an Tianlong Science and Technology Co., Ltd.
Manufacturer SRN: CN-MF-000001079
UDI-DI: 06974884776198
Basic UDI-DI: 697488477TLH019ZA
Reference: Y963H
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:38

Manufacturer products Authorised representative products Authorised representative actors View details

06974795551068

ArchiPure 96 Pro

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: RocGene (Xuzhou) Technology Limited
Manufacturer SRN: CN-MF-000024511
UDI-DI: 06974795551068
Basic UDI-DI: 6974795551006GY
Reference: ArchiPure 96 Pro
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:29

Manufacturer products Authorised representative products Authorised representative actors View details

06974591041145

H24

IVD Class AIVDR 2017/746Not intended for EU marketInstrumentProfessional testing

Manufacturer: Creative Biosciences (Guangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000034058
UDI-DI: 06974591041145
Basic UDI-DI: 6974591041006B2
Reference: H24
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 16:40

Manufacturer products Authorised representative products Authorised representative actors View details

06974454727308

CWX901/CWX902/CWX903

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Jiangsu CoWin Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008981
UDI-DI: 06974454727308
Basic UDI-DI: 697445472V21006X901-90344
Reference: CWX901
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 16:10

Manufacturer products Authorised representative products Authorised representative actors View details

06974149860068

qMate mini Dx

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentSingle use

Manufacturer: Aperbio Technologies (Suzhou) Co., Ltd
Manufacturer SRN: CN-MF-000045149
UDI-DI: 06974149860068
Basic UDI-DI: 697414986027NA
Reference: H691101
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 15:29

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Extractor System

MultiEx 096

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Four E’s Healthcare Co., Ltd.
Manufacturer SRN: CN-MF-000023274
UDI-DI: 06973698770378
Basic UDI-DI: 697369877MultiEx096SQ
Reference: MultiEx 096
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Austria
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 14:58

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Extractor System

MultiEx 032

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Four E’s Healthcare Co., Ltd.
Manufacturer SRN: CN-MF-000023274
UDI-DI: 06973698770361
Basic UDI-DI: 697369877MultiEx032RW
Reference: MultiEx 032
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Austria
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 14:58

Manufacturer products Authorised representative products Authorised representative actors View details

AutoMated Nucleic Acid Extraction System

IVD Class ANot specifiedOn the market

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802605639
Basic UDI-DI: 69268026GeneXE600000001P2
Reference: GeneX E6s
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 02.07.2026 05:34

Manufacturer products Authorised representative products Authorised representative actors View details

EZ2 Connect MDx

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: QIAGEN GmbH
Manufacturer SRN: DE-MF-000004949
UDI-DI: 04053228040576
Basic UDI-DI: 4053228IEZ2000000000001QM
Reference: 9003230
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Austria
Authorised representative: -
Last updated: 01.07.2026 19:23

Manufacturer products View details

QIAcube Connect MDx

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: QIAGEN GmbH
Manufacturer SRN: DE-MF-000004949
UDI-DI: 04053228039129
Basic UDI-DI: 4053228IQCC000000000001XU
Reference: 9003070
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Austria
Authorised representative: -
Last updated: 01.07.2026 19:23

Manufacturer products View details

RADIONE 4ch

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: KH Medical Co., Ltd.
Manufacturer SRN: KR-MF-000017883
UDI-DI: 08800204301888
Basic UDI-DI: 880002043POCF8
Reference: KM010
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 29.06.2026 01:40

Manufacturer products Authorised representative products Authorised representative actors View details