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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

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

Sequence Evolution IVD

Sequence

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: AD Nucleis
Manufacturer SRN: FR-MF-000002215
UDI-DI: 37604277000578
Basic UDI-DI: 376042770SEQUENCE86
Reference: SEQ_EVO_IVD
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: France
Authorised representative: -
Last updated: 22.07.2026 00:48

Manufacturer products View details

Sequence PREP IVD

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: AD Nucleis
Manufacturer SRN: FR-MF-000002215
UDI-DI: 37604277000646
Basic UDI-DI: 376042770SEQUENCE86
Reference: SEQ_PREP_IVD
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: -
Last updated: 21.07.2026 22:51

Manufacturer products View details

EMAG®

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026471859
Basic UDI-DI: 357302BUDI000544TP
Reference: 418591
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: France
Authorised representative: -
Last updated: 21.07.2026 22:50

Manufacturer products View details

myCROBE® Fully Automated Instrument

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696306526
Basic UDI-DI: 859569630080QR
Reference: MC100
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Czechia
Authorised representative: -
Last updated: 17.07.2026 22:55

Manufacturer products View details

croBEE® 2.0 Nucleic Acid Extraction System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696302955
Basic UDI-DI: 859569630053QN
Reference: CB2NA100
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 17.07.2026 22:55

Manufacturer products View details

croBEE Real-Time PCR System

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696302450
Basic UDI-DI: 859569630047QT
Reference: CBRT5/96
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 17.07.2026 22:55

Manufacturer products View details

myCROBE® Fully Automated Instrument

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: GeneProof a.s.
Manufacturer SRN: CZ-MF-000002370
UDI-DI: 08595696300050
Basic UDI-DI: 859569630052QL
Reference: MC100
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Czechia
Authorised representative: -
Last updated: 17.07.2026 22:55

Manufacturer products View details