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977 device results listed.

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06974968581052

FASTASeq 300 Dx

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968581052
Basic UDI-DI: 697496858FASTASeq300DxZL
Reference: SQ00021
EMDN: W02050108
EMDN description: GENETIC SYSTEM READERS
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 17:47

Manufacturer products Authorised representative products Authorised representative actors View details

06974968581021

GenoLab M Dx

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968581021
Basic UDI-DI: 697496858LabMDx-CECF
Reference: P000033
EMDN: W02050108
EMDN description: GENETIC SYSTEM READERS
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 17:47

Manufacturer products Authorised representative products Authorised representative actors View details

Single Molecule DNA Sequencer

GenoCare 1600

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968581014
Basic UDI-DI: 697496858Geno7Q
Reference: P000020
EMDN: W02050108
EMDN description: GENETIC SYSTEM READERS
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 17:47

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

Real-time PCR System

LEIA series

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shandong Bohong Gene Technology Co., Ltd.
Manufacturer SRN: CN-MF-000025971
UDI-DI: 06974901971384
Basic UDI-DI: 69749019713LEIA**KP
Reference: LEIA series
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 02.07.2026 17:42

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Extractor

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shandong Bohong Gene Technology Co., Ltd.
Manufacturer SRN: CN-MF-000025971
UDI-DI: 06974901970011
Basic UDI-DI: 6974901BH003U2
Reference: BH003
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 02.07.2026 17:42

Manufacturer products Authorised representative products Authorised representative actors View details

26974900600173

IPOCT-01

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zhuhai Shineway Biotech Co.,Ltd
Manufacturer SRN: CN-MF-000027278
UDI-DI: 26974900600173
Basic UDI-DI: 697490060IPOCT-018K
Reference: IPOCT-01
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:40

Manufacturer products Authorised representative products Authorised representative actors View details

Nucleic Acid Release Reagent

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Zhuhai Shineway Biotech Co.,Ltd
Manufacturer SRN: CN-MF-000027278
UDI-DI: 16974900602026
Basic UDI-DI: 697490060NARR-01RX
Reference: NARR-01
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:40

Manufacturer products Authorised representative products Authorised representative actors View details

Magnetic Bead Nucleic Acid Extraction Kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Zhuhai Shineway Biotech Co.,Ltd
Manufacturer SRN: CN-MF-000027278
UDI-DI: 16974900602019
Basic UDI-DI: 697490060NAEM-01LD
Reference: NAEM-01
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:40

Manufacturer products Authorised representative products Authorised representative actors View details

16974900600183

MC42-P01

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zhuhai Shineway Biotech Co.,Ltd
Manufacturer SRN: CN-MF-000027278
UDI-DI: 16974900600183
Basic UDI-DI: 697490060MC42-P01GV
Reference: MC42-P01
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:40

Manufacturer products Authorised representative products Authorised representative actors View details

16974900600169

AutoPoc MDx

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Zhuhai Shineway Biotech Co.,Ltd
Manufacturer SRN: CN-MF-000027278
UDI-DI: 16974900600169
Basic UDI-DI: 697490060AutoPocMDx2S
Reference: AutoPoc MDx
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:40

Manufacturer products Authorised representative products Authorised representative actors View details

Hand-held Nucleic Acid Detection Analyzer

SWSI-02

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Zhuhai Shineway Biotech Co.,Ltd
Manufacturer SRN: CN-MF-000027278
UDI-DI: 16974900600091
Basic UDI-DI: 697490060SWSI-0243
Reference: SWSI-02
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:40

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR Nucleic Acid Detection System

SWM-02

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Zhuhai Shineway Biotech Co.,Ltd
Manufacturer SRN: CN-MF-000027278
UDI-DI: 16974900600039
Basic UDI-DI: 697490060SWM-02PA
Reference: SWM-02
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:40

Manufacturer products Authorised representative products Authorised representative actors View details

PCR Nucleic Acid Analyzer

SWM-01

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zhuhai Shineway Biotech Co.,Ltd
Manufacturer SRN: CN-MF-000027278
UDI-DI: 06974900600018
Basic UDI-DI: 697490060SWM-01P8
Reference: SWM-01
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Austria
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 17:40

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

06974884777867

Panall 8000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Xi'an Tianlong Science and Technology Co., Ltd.
Manufacturer SRN: CN-MF-000001079
UDI-DI: 06974884777867
Basic UDI-DI: 697488477TLH011YS
Reference: Y035H
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 17:39

Manufacturer products Authorised representative products Authorised representative actors View details

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