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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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

06975938851052

NE-02-K-12；NE-02-K-12M；NE-02-K-96；NE-02-H-96；NE-02-F-96；NE-12-T-24

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

Manufacturer: GUANGZHOU BAYBIO BIO-TECH CO., LTD
Manufacturer SRN: CN-MF-000030650
UDI-DI: 06975938851052
Basic UDI-DI: 697593885ANAISV9
Reference: NE-12-T-24
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

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

06975614169044

NAT-3000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Genewise Bio Co., Ltd.
Manufacturer SRN: CN-MF-000038313
UDI-DI: 06975614169044
Basic UDI-DI: 697561416NAT1N7
Reference: NAT-3000
EMDN: W02050399
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 19:24

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

Automated Nucleic Acid Detection Reaction Construction System

AP10

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Pilot Gene Technology (Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000023002
UDI-DI: 06975578360020
Basic UDI-DI: 697557836020020001YH
Reference: 1000042
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
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

Automated Digital PCR System

AD3207

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Pilot Gene Technology (Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000023002
UDI-DI: 06975578360037
Basic UDI-DI: 697557836020010001Y6
Reference: 1200889
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
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

Microfluidic Chip

V3.0

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Pilot Gene Technology (Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000023002
UDI-DI: 06975578360006
Basic UDI-DI: 697557836030010002YT
Reference: 3100053
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

06975514360800

FC-96B,FC-96BE,FC-96GE,FC-96D,FC-96G.FC-384G,FC-1536G,FC-48D,FC-48N,FC-48T

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514360800
Basic UDI-DI: 697551436ThermalcyclerDH
Reference: FC-96G
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 19:13

Manufacturer products Authorised representative products Authorised representative actors View details

In-situ Denaturation and Hybridization Processor

DH100

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Dartmon Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000019183
UDI-DI: 06927210914634
Basic UDI-DI: 697550352DH100SERGX
Reference: DH110
EMDN: W02050101
EMDN description: NUCLEIC ACID HYBRIDIZATION UNITS
First on market country: Greece
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 19:12

Manufacturer products Authorised representative products Authorised representative actors View details

06975491760174

SEP-8、SEP-32

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Sciarray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000038307
UDI-DI: 06975491760174
Basic UDI-DI: 697549176ADEAMIPM
Reference: SEP-8
EMDN: W02050399
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 19:10

Manufacturer products Authorised representative products Authorised representative actors View details

06975491760150

SET-48、SET-96

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Sciarray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000038307
UDI-DI: 06975491760150
Basic UDI-DI: 697549176ANAEAPIYC
Reference: SET-48
EMDN: W02050299
EMDN description: MICRO-ARRAY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 19:10

Manufacturer products Authorised representative products Authorised representative actors View details