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06978704661121

Deep well plate

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Suzhou Acumen Biomedical Technology Co., LTD.
Manufacturer SRN: CN-MF-000038603
UDI-DI: 06978704661121
Basic UDI-DI: 6978704662200FM
Reference: 220001-1
EMDN: W02050185
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES
First on market country: Portugal
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 23:55

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR System

PCR Series

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Infitek Co., Ltd.
Manufacturer SRN: CN-MF-000048840
UDI-DI: 06978507780173
Basic UDI-DI: 697850778PCR10TL
Reference: IN0109
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Türkiye
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 23:37

Manufacturer products Authorised representative products Authorised representative actors View details

06978380060003

HTM-8T

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Suzhou Changhe Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000045901
UDI-DI: 06978380060003
Basic UDI-DI: 697838006CHMINIPCRYM
Reference: HTM-8T
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 23:29

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06978022400013

Pure 32

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Contin Instrument (Suzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000045197
UDI-DI: 06978022400013
Basic UDI-DI: 69780224000137D
Reference: 06978022400013
EMDN: W02050392
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 23:09

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FlashDetect

Flash20

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06977739174200
Basic UDI-DI: 697773917080200023C
Reference: 08020002
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 22:56

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FlashDetect

FlashDetect Nano

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06977739174132
Basic UDI-DI: 697773917080200063L
Reference: 08020006
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Sweden
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 22:56

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FlashDetect

Flash10

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Coyote Bioscience Co., Ltd.
Manufacturer SRN: CN-MF-000024155
UDI-DI: 06977739174125
Basic UDI-DI: 697773917080200053J
Reference: 08020005
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

NATBox System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: 06977537461755
Basic UDI-DI: 697753746CW07RE
Reference: CW07023Q
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 22:41

Manufacturer products Authorised representative products Authorised representative actors View details

06977426530005

MultiEX 024L，MultiEX 016，MultiEX 096P

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentKit

Manufacturer: Guangzhou Four E’s Scientific Co., Ltd
Manufacturer SRN: CN-MF-000043042
UDI-DI: 06977426530005
Basic UDI-DI: 6977426530015D2
Reference: MultiEX 024L，MultiEX 016，MultiEX 096P
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Germany
Authorised representative: Humiss Beratung GmbH
Last updated: 02.07.2026 22:34

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06977364170004

BHP9609

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: R&G Biotech Co., Ltd
Manufacturer SRN: CN-MF-000047000
UDI-DI: 06977364170004
Basic UDI-DI: 697736417MNAA001UH
Reference: BHP9609
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 22:29

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

06976055490162

Deaou-ART04

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: GUANGZHOU DEAOU GENE TECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000033028
UDI-DI: 06976055490162
Basic UDI-DI: 697605549002LT
Reference: Deaou-ART04
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 20:37

Manufacturer products Authorised representative products Authorised representative actors View details

06976055490018

Deaou-RT96

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: GUANGZHOU DEAOU GENE TECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000033028
UDI-DI: 06976055490018
Basic UDI-DI: 697605549001LR
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 20:37

Manufacturer products Authorised representative products Authorised representative actors View details

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

06976043630037

ICX Imager 500

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testing

Manufacturer: iCarbonX IntelliCore (Guangdong) Co., Ltd.
Manufacturer SRN: CN-MF-000045482
UDI-DI: 06976043630037
Basic UDI-DI: 697604363ICXD003Q8
Reference: 003
EMDN: W02050201
EMDN description: MICRO-ARRAY ANALYSERS
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details