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495 device results listed.

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bCUBE3

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hyris Srl
Manufacturer SRN: IT-MF-000031635
UDI-DI: 80575074300166
Basic UDI-DI: 805750743H0001XV
Reference: H0001
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 11:48

Manufacturer products View details

06979502241485

ABT-24

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06979502241485
Basic UDI-DI: 697950224MP112401MV
Reference: MP112401
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 03.07.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details

06979502241362

X-Poche 16

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06979502241362
Basic UDI-DI: 697950224PCR1116016E
Reference: MP112401
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 03.07.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

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

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

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

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

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

Thermal Cycler&Real-time PCR

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Infitek Co., Ltd.
Manufacturer SRN: CN-MF-000040107
UDI-DI: 06975488440065
Basic UDI-DI: 697548844PCR22T5
Reference: PCR-96A
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 19:07

Manufacturer products Authorised representative products Authorised representative actors View details

06975457020045

LifeReady 1000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Lifereal Biotechnology Co.,Ltd
Manufacturer SRN: CN-MF-000030319
UDI-DI: 06975457020045
Basic UDI-DI: 697545702LifeReadyNG
Reference: LifeReady 1000
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 19:04

Manufacturer products Authorised representative products Authorised representative actors View details

Real-time PCR system

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bio-gener Technology Co., Ltd.
Manufacturer SRN: CN-MF-000027988
UDI-DI: 16975412631009
Basic UDI-DI: 697541263PCRSPB
Reference: Q9602
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 19:00

Manufacturer products Authorised representative products Authorised representative actors View details

Galaxy Nano

Galaxy

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Igenesis(Shanghai)Co.,Ltd.
Manufacturer SRN: CN-MF-000001552
UDI-DI: 06975447581013
Basic UDI-DI: 697544758GALAXYU9
Reference: 101-0022-02
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 19:00

Manufacturer products Authorised representative products Authorised representative actors View details

06975409760012

Real-time qPCR System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou LongGene Scientific Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000024510
UDI-DI: 06975409760012
Basic UDI-DI: 6975409760005DD
Reference: Q2000A
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 18:55

Manufacturer products Authorised representative products Authorised representative actors View details