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06974884777713

Fascan 48E, Fascan 48S, Fascan 16E, Fascan 16S

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Xi'an Tianlong Science and Technology Co., Ltd.
Manufacturer SRN: CN-MF-000001079
UDI-DI: 06974884777713
Basic UDI-DI: 697488477TLH014YY
Reference: Y016B
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
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

06974884776204

iGenebox 3A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Xi'an Tianlong Science and Technology Co., Ltd.
Manufacturer SRN: CN-MF-000001079
UDI-DI: 06974884776204
Basic UDI-DI: 697488477TLH018Z8
Reference: Y062H
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:38

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

Portable Rapid Nucleic Acid Detector GenCase-S

GenCase-S

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Qingdao MGI Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000022546
UDI-DI: 06974856880410
Basic UDI-DI: 697485688PRNAD3B
Reference: 900-000710-00
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Latvia
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:37

Manufacturer products Authorised representative products Authorised representative actors View details

Genetic Sequencer DNBSEQ-E25

DNBSEQ-E25, DNBSEQ-E25A, 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: 06974856880021
Basic UDI-DI: 697485688SEQ2U
Reference: 900-000850-00
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 17:37

Manufacturer products Authorised representative products Authorised representative actors View details

Easy Amp Real-time Fluorescence Isothermal Detection System

HWTS 1600P,HWTS 1600S

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: 06974849366389
Basic UDI-DI: 697484936W02050199W7
Reference: HWTS-EQ002
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:36

Manufacturer products Authorised representative products Authorised representative actors View details

06974795551983

iFIND S2 、iFIND S4 、iFIND S8

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: RocGene (Xuzhou) Technology Limited
Manufacturer SRN: CN-MF-000024511
UDI-DI: 06974795551983
Basic UDI-DI: 697479555iFIND6K
Reference: iFIND S2
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
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

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

06974737220205

Automatic Nucleic Acid Detection and Analysis System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shanghai Rendu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000018869
UDI-DI: 06974737220205
Basic UDI-DI: 697473722AutoSAT47
Reference: AutoSAT
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:23

Manufacturer products Authorised representative products Authorised representative actors View details

C10 easyPCR System

C10

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689626018
Basic UDI-DI: 697468962601S7
Reference: N/A
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 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

06974689625219

D20

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689625219
Basic UDI-DI: 697468962521S8
Reference: NA
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Belgium
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

D30 Automatic Digital PCR System

D30

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689625189
Basic UDI-DI: 697468962518SK
Reference: 30175
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 17:15

Manufacturer products Authorised representative products Authorised representative actors View details

D50 Automatic Digital PCR System

D50

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689625172
Basic UDI-DI: 697468962517SH
Reference: 30171
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 17:15

Manufacturer products Authorised representative products Authorised representative actors View details

Chip Reader

Chip Reader R1

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689625103
Basic UDI-DI: 697468962510S3
Reference: 30052
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 17:15

Manufacturer products Authorised representative products Authorised representative actors View details

Drop Maker

Drop Maker M1

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689625097
Basic UDI-DI: 697468962509SJ
Reference: 30002
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 17:15

Manufacturer products Authorised representative products Authorised representative actors View details