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YJSeq 300 Dx Sequencing Kit

YJSeq 300 Dx Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai YJMED BioTechnology Co., Ltd.
Manufacturer SRN: CN-MF-000055692
UDI-DI: 06977334213021
Basic UDI-DI: 697733421RB01KG
Reference: YJSeq 300 Dx Sequencing Kit
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 22:26

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YJSeq 300 Dx Sequencing System

YJSeq 300 Dx

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shanghai YJMED BioTechnology Co., Ltd.
Manufacturer SRN: CN-MF-000055692
UDI-DI: 06977334213014
Basic UDI-DI: 697733421YJ300KJ
Reference: YJSeq 300 Dx
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 22:26

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EUYI Nucleic Acid Extraction Reagent (Manual method)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen YOUYI Bioscience Ltd.
Manufacturer SRN: CN-MF-000034584
UDI-DI: 06976457970910
Basic UDI-DI: 697645797FYT2G
Reference: 100FYT-48
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 21:37

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Molecular Hybridizer

MH48

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen YOUYI Bioscience Ltd.
Manufacturer SRN: CN-MF-000034584
UDI-DI: 06976457970071
Basic UDI-DI: 697645797MH48TM
Reference: 200MH48
EMDN: W02050101
EMDN description: NUCLEIC ACID HYBRIDIZATION UNITS
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 21:36

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Real-time fluorescence quantitative PCR analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Chongqing ME Instruments Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000035349
UDI-DI: 06976045290024
Basic UDI-DI: 697604529MQ96-X4QM
Reference: MQ96-X4
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 20:36

Manufacturer products Authorised representative products Authorised representative actors View details

QPursue-6kDx Nanopore Sequencer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Qitan Taike Biotechnology Ltd., Chengdu
Manufacturer SRN: CN-MF-000040515
UDI-DI: 06976019890090
Basic UDI-DI: 697601989OY003PD
Reference: OY003001
EMDN: W02050115
EMDN description: DNA SYNTHESIZERS
First on market country: Greece
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 20:34

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QNome-3841 Nanopore Sequencer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Qitan Taike Biotechnology Ltd., Chengdu
Manufacturer SRN: CN-MF-000040515
UDI-DI: 06976019890038
Basic UDI-DI: 697601989OY001P9
Reference: OY001001
EMDN: W02050115
EMDN description: DNA SYNTHESIZERS
First on market country: Greece
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 20:34

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QNome-3841hexDx Nanopore Sequencer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Qitan Taike Biotechnology Ltd., Chengdu
Manufacturer SRN: CN-MF-000040515
UDI-DI: 06976019890021
Basic UDI-DI: 697601989OY002PB
Reference: OY002001
EMDN: W02050115
EMDN description: DNA SYNTHESIZERS
First on market country: Greece
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 20:34

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CHK Biotech

CHK-3200 CHK-16S CHK-800

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shanghai Chuangkun Biotech Inc.
Manufacturer SRN: CN-MF-000032705
UDI-DI: 06976014644018
Basic UDI-DI: 697601464ANAE01DA
Reference: N/A
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Greece
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 20:34

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Genetic Sequencer DNBSEQ-T1+

DNBSEQ-T1+

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shenzhen MGI Biological Electronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044825
UDI-DI: 06975996270024
Basic UDI-DI: 697599627SEQ3Z
Reference: 900-000989-00
EMDN: W02050108
EMDN description: GENETIC SYSTEM READERS
First on market country: Latvia
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 20:28

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Nucleic Acid Purification System

NAE24 PIus

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: SINGLERA GENOMICS (JIANGSU) LTD.
Manufacturer SRN: CN-MF-000033428
UDI-DI: 06975970650026
Basic UDI-DI: 697597065INST04ZN
Reference: INST040024CE
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Purification System

CaptureRevo NAE24

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: SINGLERA GENOMICS (JIANGSU) LTD.
Manufacturer SRN: CN-MF-000033428
UDI-DI: 06975970650019
Basic UDI-DI: 697597065021QE
Reference: INST020024CE
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 20:27

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06975760470131

RS3204 , RS3205, RS3206, RS3207

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Suzhou Precigenome Ltd, Co;
Manufacturer SRN: CN-MF-000024105
UDI-DI: 06975760470131
Basic UDI-DI: 697576047RS32S3
Reference: RS3204 , RS3205, RS3206, RS3207
EMDN: W02050180
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES
First on market country: Spain
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 02.07.2026 19:45

Manufacturer products Authorised representative products Authorised representative actors View details

Gene Sequencer

Sikun Rapid GS 480

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Sikun Life Science Co., Ltd.
Manufacturer SRN: CN-MF-000047921
UDI-DI: 06975608185128
Basic UDI-DI: 697560818model03FD
Reference: 5128
EMDN: W02050108
EMDN description: GENETIC SYSTEM READERS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 19:22

Manufacturer products Authorised representative products Authorised representative actors View details

Sikun 2000

Gene Sequencer (Sikun 2000 & Sikun 1000 & Sikun 500 & Sikun 2000 pro & Sikun 1000 pro & Sikun 500 pro)

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Sikun Life Science Co., Ltd.
Manufacturer SRN: CN-MF-000047921
UDI-DI: 06975608185067
Basic UDI-DI: 697560818model01F9
Reference: 5067
EMDN: W02050115
EMDN description: DNA SYNTHESIZERS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 19:22

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Nucleic Acid Detection Analyzer

Ideal 66

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangdong RunPon Bioscience Inc.
Manufacturer SRN: CN-MF-000025972
UDI-DI: 06975600660043
Basic UDI-DI: 697560066Ideal66MQ
Reference: N/A
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Share info GmbH
Last updated: 02.07.2026 19:22

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Nucleic Acid Detection Analyzer

Ideal 36

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangdong RunPon Bioscience Inc.
Manufacturer SRN: CN-MF-000025972
UDI-DI: 06975600660036
Basic UDI-DI: 697560066Ideal36MF
Reference: N/A
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Share info GmbH
Last updated: 02.07.2026 19:22

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Nucleic Acid Detection Analyzer

Ideal 30

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangdong RunPon Bioscience Inc.
Manufacturer SRN: CN-MF-000025972
UDI-DI: 06975600660029
Basic UDI-DI: 697560066Ideal30M3
Reference: WO2050116
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Share info GmbH
Last updated: 02.07.2026 19:22

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR Instrument

P810

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Guangdong RunPon Bioscience Inc.
Manufacturer SRN: CN-MF-000025972
UDI-DI: 06975600660005
Basic UDI-DI: 697560066I11NS
Reference: P810
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Share info GmbH
Last updated: 02.07.2026 19:22

Manufacturer products Authorised representative products Authorised representative actors View details

Magnetic Rod Sleeve

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingSingle use

Manufacturer: Pilot Gene Technology (Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000023002
UDI-DI: 06975578360273
Basic UDI-DI: 697557836030020002Z6
Reference: 3060340
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 19:19

Manufacturer products Authorised representative products Authorised representative actors View details