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09.07.2026 13:08

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Active filter:Manufacturer SRN:CN-MF-000019512

197 device results listed.

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Neisseria gonorrhoeae, Chlamydia trachomatis, Ureaplasma urealyticum Nucleic Acid Detection Kit (Fluorescent PCR)

BSJ02S1, BSJ02M1, BSJ02L1, BSJ02S1A, BSJ02M1A, BSJ02L1A

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843227771
Basic UDI-DI: 697384322BSJ02JC
Reference: BSJ02L1
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.06.2026 12:08

Manufacturer products Authorised representative products Authorised representative actors View details

Neisseria gonorrhoeae, Chlamydia trachomatis Nucleic Acid Detection Kit (Fluorescent PCR)

BSJ02S1, BSJ02M1, BSJ02L1, BSJ02S1A, BSJ02M1A, BSJ02L1A

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843227757
Basic UDI-DI: 697384322BSJ02JC
Reference: BSJ02M1A
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.06.2026 12:08

Manufacturer products Authorised representative products Authorised representative actors View details

Neisseria gonorrhoeae, Chlamydia trachomatis Nucleic Acid Detection Kit (Fluorescent PCR)

BSJ02S1, BSJ02M1, BSJ02L1, BSJ02S1A, BSJ02M1A, BSJ02L1A

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843227740
Basic UDI-DI: 697384322BSJ02JC
Reference: BSJ02L1A
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.06.2026 12:08

Manufacturer products Authorised representative products Authorised representative actors View details

GenePure 96 Nucleic Acid Purification System

-

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843220604
Basic UDI-DI: 697384322NPA003K4
Reference: NPA-96T
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.06.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

GenePure 96 Nucleic Acid Purification System

-

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843220611
Basic UDI-DI: 697384322NPA003K4
Reference: NPA-96E
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.06.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

QuantGene 9600 Fluorescent Quantitative Detection System

-

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843220635
Basic UDI-DI: 697384322FQD005GY
Reference: FQD-96C(EA5)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.06.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

QuantGene 9600 Fluorescent Quantitative Detection System

-

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843220642
Basic UDI-DI: 697384322FQD005GY
Reference: FQD-96C(EA6)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.06.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

GenePure Pro Nucleic Acid Purification System

-

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843220666
Basic UDI-DI: 697384322NPA002K2
Reference: NPA-32E
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.06.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Nucleic Acid Purification and Real Time PCR System

-

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843220697
Basic UDI-DI: 697384322FQD006H2
Reference: FQD-A1600(EA5)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.06.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Nucleic Acid Purification and Real Time PCR System

-

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843220703
Basic UDI-DI: 697384322FQD006H2
Reference: FQD-A1600(EA6)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.06.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

LineGene MiniS Fluorescent Quantitative Detection System

-

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843220727
Basic UDI-DI: 697384322FQD002GS
Reference: FQD-16B(EA4)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.06.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

GeneExplorer Thermal Cycler

-

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843220741
Basic UDI-DI: 697384322TC001H3
Reference: GE-96S
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.06.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

GeneExplorer Thermal Cycler

-

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843220758
Basic UDI-DI: 697384322TC001H3
Reference: GE-48DG
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.06.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

LineGene 9600 Plus Fluorescent Quantitative Detection System

-

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843220772
Basic UDI-DI: 697384322FQD004GW
Reference: FQD-96A(EA4)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.06.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

LineGene 9600 Plus Fluorescent Quantitative Detection System

-

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843220789
Basic UDI-DI: 697384322FQD004GW
Reference: FQD-96A(EA5)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.06.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

LineGene 9600 Plus Fluorescent Quantitative Detection System

-

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843220796
Basic UDI-DI: 697384322FQD004GW
Reference: FQD-96A(EA6)
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.06.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

GeneExplorer Thermal Cycler

-

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843220826
Basic UDI-DI: 697384322TC001H3
Reference: GE-384G
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.06.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

GeneExplorer Thermal Cycler

-

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843220833
Basic UDI-DI: 697384322TC001H3
Reference: GE-4I
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.06.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

GeneExplorer Thermal Cycler

-

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843220840
Basic UDI-DI: 697384322TC001H3
Reference: GE-48D
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.06.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

GeneExplorer Thermal Cycler

-

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843220857
Basic UDI-DI: 697384322TC001H3
Reference: GE-48DS
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.06.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details