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Rotavirus (group A/B/C) Diagnostic Kit (PCR-Fluorescence Probing)

48 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892626
Basic UDI-DI: B-06974674892626
Reference: 18-01-0022
EMDN: W0105040506
EMDN description: ROTAVIRUS - NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:16

Manufacturer products Authorised representative products Authorised representative actors View details

Coxsackie virus group A type 16 (CA16) Diagnostic Kit (PCR-Fluorescence Probing)

48 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892602
Basic UDI-DI: B-06974674892602
Reference: 18-01-0020
EMDN: W0105040502
EMDN description: ENTEROVIRUS - NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:16

Manufacturer products Authorised representative products Authorised representative actors View details

Enterovirus type 71 (EV71) Diagnostic Kit (PCR-Fluorescence Probing)

48 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892596
Basic UDI-DI: B-06974674892596
Reference: 18-01-0019
EMDN: W0105040502
EMDN description: ENTEROVIRUS - NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:16

Manufacturer products Authorised representative products Authorised representative actors View details

Enterovirus Universal Diagnostic Kit (PCR-Fluorescence Probing)

48 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892589
Basic UDI-DI: B-06974674892589
Reference: 18-01-0018
EMDN: W0105040502
EMDN description: ENTEROVIRUS - NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:16

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A+B virus Diagnostic Kit (PCR-Fluorescence Probing)

48 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892527
Basic UDI-DI: B-06974674892527
Reference: 18-01-0012
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:16

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A (H1N1) Diagnostic Kit (PCR-Fluorescence Probing)

48 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892510
Basic UDI-DI: B-06974674892510
Reference: 18-01-0011
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:16

Manufacturer products Authorised representative products Authorised representative actors View details

Mutation of SARS-CoV-2 nucleic acid Detection Kit (Real Time PCR)

48 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674891858
Basic UDI-DI: B-06974674891858
Reference: 18-02-0129
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:12

Manufacturer products Authorised representative products Authorised representative actors View details

Novel Coronavirus(SARS-CoV-2) Nucleic Acid Detection Kit (Isothermal Amplification)

48 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674891841
Basic UDI-DI: B-06974674891841
Reference: 18-02-0128
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:12

Manufacturer products Authorised representative products Authorised representative actors View details

2019-nCoV Nucleic acid Detection Kit (Real Time PCR)

48 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674891834
Basic UDI-DI: B-06974674891834
Reference: 18-02-0127
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:12

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Nuclear Acid Detection Kit (Real Time PCR)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shanghai GeneoDx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000029299
UDI-DI: 06974593880117
Basic UDI-DI: B-06974593880117
Reference: GZ-MPV024
EMDN: W0105040599
EMDN description: VIROLOGY - NA REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:00

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus Rapid Test Kit (Colloidal gold method)

CR035

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473306850
Basic UDI-DI: B-06974473306850
Reference: CR035
EMDN: W0105040501
EMDN description: ADENOVIRUS - NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 19:11

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus Antigen Rapid Test Kit (Colloidal gold method)

CR032

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000023810
UDI-DI: 06974473300513
Basic UDI-DI: B-06974473300513
Reference: CR032
EMDN: W0105040506
EMDN description: ROTAVIRUS - NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 19:09

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 (SARS-CoV-2) Antigen Test Kit

1 test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Fanttest Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000026134
UDI-DI: 06974408020059
Basic UDI-DI: B-06974408020059
Reference: ICO-A502-P1
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 19:07

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 (SARS-CoV-2) Antigen Test Kit

1 test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Fanttest Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000026134
UDI-DI: 06974408020011
Basic UDI-DI: B-06974408020011
Reference: ICO-A502-A1
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 06.07.2026 19:07

Manufacturer products Authorised representative products Authorised representative actors View details

06974323012320

Multiple Real-Time PCR Detection Kit for Norovirus GI/GII

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323012320
Basic UDI-DI: B-06974323012320
Reference: A2602YH-50T
EMDN: W0105040516
EMDN description: NOROVIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974323012313

Multiple Real-Time PCR Detection Kit for Norovirus GI/GII

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323012313
Basic UDI-DI: B-06974323012313
Reference: A2602YH-25T
EMDN: W0105040516
EMDN description: NOROVIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974323012252

Duplex Real-Time PCR Diagnostic Kit for Rapid Detection of Ebola-Zaire

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323012252
Basic UDI-DI: B-06974323012252
Reference: A2532-50T
EMDN: W0105040528
EMDN description: EBOLA (FILOVIRUS) - NA REAGENTS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974323012245

Duplex Real-Time PCR Diagnostic Kit for Rapid Detection of Ebola-Zaire

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323012245
Basic UDI-DI: B-06974323012245
Reference: A2532-25T
EMDN: W0105040528
EMDN description: EBOLA (FILOVIRUS) - NA REAGENTS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:49

Manufacturer products Authorised representative products Authorised representative actors View details

06974323012047

Real-time PCR Detection Kit for Monkeypox Virus

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323012047
Basic UDI-DI: B-06974323012047
Reference: D2361YH
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:49

Manufacturer products Authorised representative products Authorised representative actors View details

06974323012030

Real-time PCR Detection Kit for Monkeypox Virus

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323012030
Basic UDI-DI: B-06974323012030
Reference: D2361YH
EMDN: W0105040532
EMDN description: MONKEYPOX VIRUS / MPOX - NA REAGENT
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 18:49

Manufacturer products Authorised representative products Authorised representative actors View details