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Genetic Sequencer DNBSEQ-G99A

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Wuhan MGI Tech Co., Ltd.
Manufacturer SRN: CN-MF-000018732
UDI-DI: 06974318131074
Basic UDI-DI: 697431813SEQSY
Reference: 900-000628-00
EMDN: W02050108
EMDN description: GENETIC SYSTEM READERS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.06.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

Genetic Sequencer HELICON® G400

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Wuhan MGI Tech Co., Ltd.
Manufacturer SRN: CN-MF-000018732
UDI-DI: 06974318131906
Basic UDI-DI: 697431813SEQSY
Reference: 900-000742-00
EMDN: W02050108
EMDN description: GENETIC SYSTEM READERS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.06.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

Genetic Sequencer HELICON® G50

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Wuhan MGI Tech Co., Ltd.
Manufacturer SRN: CN-MF-000018732
UDI-DI: 06974318131913
Basic UDI-DI: 697431813SEQSY
Reference: 900-000743-00
EMDN: W02050108
EMDN description: GENETIC SYSTEM READERS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.06.2026 13:05

Manufacturer products Authorised representative products Authorised representative actors View details

06974454727315

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Jiangsu CoWin Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008981
UDI-DI: 06974454727315
Basic UDI-DI: 697445472V21006X901-90344
Reference: CWX902
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 13:00

Manufacturer products Authorised representative products Authorised representative actors View details

06974454727322

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Jiangsu CoWin Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008981
UDI-DI: 06974454727322
Basic UDI-DI: 697445472V21006X901-90344
Reference: CWX903
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 13:00

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565042

IVD Class AIVDR 2017/746On the marketInstrumentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565042
Basic UDI-DI: 697454156003KX
Reference: AU1001S
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:57

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565059

IVD Class AIVDR 2017/746On the marketInstrumentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565059
Basic UDI-DI: 697454156003KX
Reference: AU1001-96
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:57

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565219

IVD Class AIVDR 2017/746On the marketInstrumentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565219
Basic UDI-DI: 697454156006L5
Reference: BTK-1
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:57

Manufacturer products Authorised representative products Authorised representative actors View details

Uni-medica

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen Uni-medica Technology Co., Ltd.
Manufacturer SRN: CN-MF-000022946
UDI-DI: 06974561520120
Basic UDI-DI: 697456152NFAST32ABE
Reference: 15.09.001.02
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.06.2026 12:57

Manufacturer products Authorised representative products Authorised representative actors View details

06974737220212

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shanghai Rendu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000018869
UDI-DI: 06974737220212
Basic UDI-DI: 697473722AutoSAT47
Reference: AutoSAT Plus
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.06.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

06974795551990

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: RocGene (Xuzhou) Technology Limited
Manufacturer SRN: CN-MF-000024511
UDI-DI: 06974795551990
Basic UDI-DI: 697479555iFIND6K
Reference: iFIND S4
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974795552003

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: RocGene (Xuzhou) Technology Limited
Manufacturer SRN: CN-MF-000024511
UDI-DI: 06974795552003
Basic UDI-DI: 697479555iFIND6K
Reference: iFIND S8
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:50

Manufacturer products Authorised representative products Authorised representative actors View details

Easy Amp Real-time Fluorescence Isothermal Detection System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366396
Basic UDI-DI: 697484936W02050199W7
Reference: HWTS-EQ001
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.06.2026 12:48

Manufacturer products Authorised representative products Authorised representative actors View details

EudemonTM AIO800

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849368666
Basic UDI-DI: 697484936W02050199W7
Reference: HWTS-EQ007
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.06.2026 12:48

Manufacturer products Authorised representative products Authorised representative actors View details

Genetic Sequencer DNBSEQ-T20×2

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Qingdao MGI Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000022546
UDI-DI: 06974856880137
Basic UDI-DI: 697485688SEQ2U
Reference: 900-000542-00
EMDN: W02050108
EMDN description: GENETIC SYSTEM READERS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.06.2026 12:48

Manufacturer products Authorised representative products Authorised representative actors View details

Genetic Sequencer DNBSEQ-E25A

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Qingdao MGI Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000022546
UDI-DI: 06974856880151
Basic UDI-DI: 697485688SEQ2U
Reference: 900-000566-00
EMDN: W02050108
EMDN description: GENETIC SYSTEM READERS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.06.2026 12:48

Manufacturer products Authorised representative products Authorised representative actors View details

06974884777577

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Xi'an Tianlong Science and Technology Co., Ltd.
Manufacturer SRN: CN-MF-000001079
UDI-DI: 06974884777577
Basic UDI-DI: 697488477TLH001YP
Reference: Y012H-01
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:47

Manufacturer products Authorised representative products Authorised representative actors View details

06974884777584

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Xi'an Tianlong Science and Technology Co., Ltd.
Manufacturer SRN: CN-MF-000001079
UDI-DI: 06974884777584
Basic UDI-DI: 697488477TLH015Z2
Reference: TL59BEH
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:47

Manufacturer products Authorised representative products Authorised representative actors View details

06974884777591

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Xi'an Tianlong Science and Technology Co., Ltd.
Manufacturer SRN: CN-MF-000001079
UDI-DI: 06974884777591
Basic UDI-DI: 697488477TLH015Z2
Reference: TL59VH
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:47

Manufacturer products Authorised representative products Authorised representative actors View details

06974884777607

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Xi'an Tianlong Science and Technology Co., Ltd.
Manufacturer SRN: CN-MF-000001079
UDI-DI: 06974884777607
Basic UDI-DI: 697488477TLH015Z2
Reference: TL59XH
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:47

Manufacturer products Authorised representative products Authorised representative actors View details