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Automated TRCR Real-time Monitor TRCReady-80

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04562185395259
Basic UDI-DI: 45601892100040037K
Reference: 0023950
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 31.07.2026 06:01

Manufacturer products Authorised representative products Authorised representative actors View details

FilmArray® 2.0 Instrument

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BioFire Diagnostics, LLC
Manufacturer SRN: US-MF-000003311
UDI-DI: 00815381020031
Basic UDI-DI: 357302BUDI000020SG
Reference: FLM2-ASY-0001
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 30.07.2026 02:34

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDxTM 200

WonDx-1001, WonDx-1002, WonDx-1003, WonDx-1004, WonDx-1005, WonDx-1006, WonDx-1007, WonDx-1008, U-CardDx 200-1001, U-CardDx 200-1002, U-CardDx 200-1003, U-CardDx 200-1004,U-CardDx 200-1005,U-CardDx 200-1006, U-CardDx 200-1007,U-CardDx 200-1008

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850506
Basic UDI-DI: 69332898CE3186FW
Reference: WK46
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 29.07.2026 23:07

Manufacturer products Authorised representative products Authorised representative actors View details

SpotFire®

IVD Class AIVDR 2017/746On the marketInstrumentNear-patient testingProfessional testing

Manufacturer: BioFire Diagnostics, LLC
Manufacturer SRN: US-MF-000003311
UDI-DI: 00815381020369
Basic UDI-DI: 357302BUDI000917U8
Reference: FAST-ASY-0002
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: France
Authorised representative: bioMérieux SA
Last updated: 29.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDxTM 200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850513
Basic UDI-DI: 69332898CE3186FW
Reference: WK47
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 29.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDxTM 200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850520
Basic UDI-DI: 69332898CE3186FW
Reference: WK48
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 29.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDxTM 200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850537
Basic UDI-DI: 69332898CE3186FW
Reference: WK49
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 29.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

QIAsymphony Connect

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: QIAGEN GmbH
Manufacturer SRN: DE-MF-000004949
UDI-DI: 04053228049982
Basic UDI-DI: 4053228IQSC000000000001MF
Reference: 9003450
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Germany
Authorised representative: -
Last updated: 29.07.2026 09:33

Manufacturer products View details

08885019710421

800705

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019710421
Basic UDI-DI: 888501971800705WZ
Reference: 800705
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 23.07.2026 23:06

Manufacturer products Authorised representative products Authorised representative actors View details

Vazyme Hybrid System

Hybrid-I-M

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315739436
Basic UDI-DI: 6973315739436B8
Reference: Hybrid-I-M
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: 22.07.2026 23:09

Manufacturer products Authorised representative products Authorised representative actors View details

Vazyme Hybrid System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06973315739443
Basic UDI-DI: 6973315739436B8
Reference: Hybrid-Ia-M
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

06975514360817

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: 06975514360817
Basic UDI-DI: 697551436ThermalcyclerDH
Reference: FC-48N
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 22.07.2026 17:28

Manufacturer products Authorised representative products Authorised representative actors View details

06975514360824

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514360824
Basic UDI-DI: 697551436ThermalcyclerDH
Reference: FC-96B
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 22.07.2026 17:28

Manufacturer products Authorised representative products Authorised representative actors View details

06975514360831

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514360831
Basic UDI-DI: 697551436ThermalcyclerDH
Reference: FC-96GE
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 22.07.2026 17:28

Manufacturer products Authorised representative products Authorised representative actors View details

06975514360848

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514360848
Basic UDI-DI: 697551436ThermalcyclerDH
Reference: FC-96BE
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 22.07.2026 17:28

Manufacturer products Authorised representative products Authorised representative actors View details

06975514360855

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514360855
Basic UDI-DI: 697551436ThermalcyclerDH
Reference: FC-96D
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 22.07.2026 17:28

Manufacturer products Authorised representative products Authorised representative actors View details

06975514360862

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514360862
Basic UDI-DI: 697551436ThermalcyclerDH
Reference: FC-384G
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 22.07.2026 17:28

Manufacturer products Authorised representative products Authorised representative actors View details

06975514360879

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514360879
Basic UDI-DI: 697551436ThermalcyclerDH
Reference: FC-1536G
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 22.07.2026 17:28

Manufacturer products Authorised representative products Authorised representative actors View details

06975514360886

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514360886
Basic UDI-DI: 697551436ThermalcyclerDH
Reference: FC-48D
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 22.07.2026 17:28

Manufacturer products Authorised representative products Authorised representative actors View details

06975514360893

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514360893
Basic UDI-DI: 697551436ThermalcyclerDH
Reference: FC-48T
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 22.07.2026 17:28

Manufacturer products Authorised representative products Authorised representative actors View details