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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

06975514360077

IVD Class ANot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514360077
Basic UDI-DI: 697551436BFQP001PX
Reference: BFQP-482C
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: 22.07.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

06975514360053

IVD Class ANot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514360053
Basic UDI-DI: 697551436BFQP001PX
Reference: BFQP-484C
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: 22.07.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

06975514360060

IVD Class ANot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514360060
Basic UDI-DI: 697551436BFQP001PX
Reference: BFQP-485C
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: 22.07.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

06975514360046

IVD Class ANot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514360046
Basic UDI-DI: 697551436BFQP001PX
Reference: BFQP-9650
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: 22.07.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

06975514360084

IVD Class ANot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514360084
Basic UDI-DI: 697551436BFQP001PX
Reference: BFQP-965C
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: 22.07.2026 06:36

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

06975514360022

IVD Class ANot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514360022
Basic UDI-DI: 697551436BFQP001PX
Reference: BFQP-4840
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: 21.07.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors 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

06975514360039

IVD Class ANot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514360039
Basic UDI-DI: 697551436BFQP001PX
Reference: BFQP-4850
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: 21.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors 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

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: 08595696302467
Basic UDI-DI: 859569630047QT
Reference: CBRT4/96
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: -
Authorised representative: -
Last updated: 17.07.2026 22:39

Manufacturer products View details