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Real time fluorescence quantitative PCR Device

OP-qPCR1600C

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Wuxi Opulen Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000023008
UDI-DI: 06975061571605
Basic UDI-DI: 697506157OPqPCR1600C65
Reference: 1722023
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Germany
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 17:59

Manufacturer products Authorised representative products Authorised representative actors View details

Full-Automatic Nucleic Acid Extraction and Purification Instrument

MN-9600B

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Jiangsu Q-Array Co.,Ltd.
Manufacturer SRN: CN-MF-000044646
UDI-DI: 06975050590204
Basic UDI-DI: 697505059020JG
Reference: MN-9600B
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Caretechion GmbH
Last updated: 02.07.2026 17:57

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time Quantitative Thermal Cycler

MA-688，MA-1610Q，MA-1620Q，MA-1630Q，MA-1640Q

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Jiangsu Q-Array Co.,Ltd.
Manufacturer SRN: CN-MF-000044646
UDI-DI: 06975050590006
Basic UDI-DI: 697505059000JA
Reference: MA-688
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Caretechion GmbH
Last updated: 02.07.2026 17:57

Manufacturer products Authorised representative products Authorised representative actors View details

GeneMind

FASTASeq S Dx

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968581090
Basic UDI-DI: 697496858AH01FASTASeqSYL
Reference: SQ00078
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

GeneMind

SURFSeq Q Dx

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968581083
Basic UDI-DI: 697496858AG01SURFSeqQDx6M
Reference: SQ00065
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

06974968581069

SURFSeq 5000 Dx

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: GeneMind Biosciences Co., Ltd.
Manufacturer SRN: CN-MF-000025785
UDI-DI: 06974968581069
Basic UDI-DI: 697496858AE01SURF5000PH
Reference: SQ00026
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

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

Automated PCR Analysis System

FlashDx® sSPRT™ 4T

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: FlashDx Shenzhen Inc
Manufacturer SRN: CN-MF-000025748
UDI-DI: 06974936201050
Basic UDI-DI: 6974936202010408121UB
Reference: FlashDx® sSPRT™ 4T
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 17:45

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Nucleic Acid Detection System

FlashDx-1000-E

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: FlashDx Shenzhen Inc
Manufacturer SRN: CN-MF-000025748
UDI-DI: 06974936201036
Basic UDI-DI: 697493620FDX1000EVS
Reference: FlashDx-1000-E
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 17:45

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