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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

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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

06975514361043

BFQP-48、BFQP-96、BFQP-16

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514361043
Basic UDI-DI: 697551436BFQP001PX
Reference: BFQP-1620
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 28.07.2026 06:56

Manufacturer products Authorised representative products Authorised representative actors View details

06975514361050

IVD Class ANot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514361050
Basic UDI-DI: 697551436BFQP001PX
Reference: BFQP-1650
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 28.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

PE-Buffer

IVD Class ANot specifiedOn the marketProfessional testingReagent

Manufacturer: Cube Dx GmbH
Manufacturer SRN: AT-MF-000013909
UDI-DI: 09120127730138
Basic UDI-DI: 912012773HDR-005XM
Reference: 09120127730138
EMDN: W02050285
EMDN description: MICRO-ARRAY INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: -
Last updated: 26.07.2026 18:08

Manufacturer products View details

GINA 500

IVD Class ANot specifiedOn the marketKitProfessional testingReagentSingle use

Manufacturer: Cube Dx GmbH
Manufacturer SRN: AT-MF-000013909
UDI-DI: 09120127730244
Basic UDI-DI: 912012773GINA7H
Reference: 09120127730244
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: -
Authorised representative: -
Last updated: 26.07.2026 18:08

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

SONOGEN XP

IVD generalIVDDOn the marketProfessional testing

Manufacturer: INTLAB AG
Manufacturer SRN: CH-MF-000032746
UDI-DI: D-SONOGEN_XPER
Basic UDI-DI: B-SONOGEN_XPER
Reference: n.a.
EMDN: W02050192
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: INTLAB Deutschland GmbH
Last updated: 23.07.2026 19:57

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