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SARS-CoV-2(COVID-19)Antibody Rapid Detection Kit(Lateral Flow Method)

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674891490
Basic UDI-DI: B-06974674891490
Reference: 18-02-0130
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:11

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2(COVID-19)Antigen Rapid Detection Kit(Lateral Flow Method)

50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674890813
Basic UDI-DI: B-06974674890813
Reference: 18-02-0017
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:10

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2(COVID-19)Antigen Rapid Detection Kit(Lateral Flow Method)

100 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674890820
Basic UDI-DI: B-06974674890820
Reference: 18-02-0018
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:10

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2(COVID-19)Antigen Rapid Detection Kit(Lateral Flow Method)

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674890806
Basic UDI-DI: B-06974674890806
Reference: 18-02-0016
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:10

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565639

20 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565639
Basic UDI-DI: B-06974541565639
Reference: ICA2114-11
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Croatia
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:51

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565622

1 test/kit

IVD generalIVDDOn the marketKitReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565622
Basic UDI-DI: B-06974541565622
Reference: ICA2114-11
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Cyprus
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565615

20 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565615
Basic UDI-DI: B-06974541565615
Reference: ICA2508
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565608

1 Test/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565608
Basic UDI-DI: B-06974541565608
Reference: ICA2508
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565561

1 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565561
Basic UDI-DI: B-06974541565561
Reference: ICA2521
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565578

20 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565578
Basic UDI-DI: B-06974541565578
Reference: ICA2521
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565530

1 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565530
Basic UDI-DI: B-06974541565530
Reference: ICA2501
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565554

20 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565554
Basic UDI-DI: B-06974541565554
Reference: ICA2501
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Belgium
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus（MPxV）IgM/IgG Rapid Detection Kit （Immunochromatography Assay）

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521005988
Basic UDI-DI: B-06974521005988
Reference: SUPL031025
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:43

Manufacturer products Authorised representative products Authorised representative actors View details

HPIV Antigen Rapid Test (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521005681
Basic UDI-DI: B-06974521005681
Reference: SUPF094025
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:43

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovims (ADV) Antigen Rapid Test (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521005605
Basic UDI-DI: B-06974521005605
Reference: SUPF063025
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:42

Manufacturer products Authorised representative products Authorised representative actors View details

HPIV Antigen Rapid Test (Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521004592
Basic UDI-DI: B-06974521004592
Reference: SUPL026025
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:39

Manufacturer products Authorised representative products Authorised representative actors View details

2019-Novel Coronavirus(2019-nCoV) IgG/IgM GICA Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521004585
Basic UDI-DI: B-06974521004585
Reference: SUPG223025
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:39

Manufacturer products Authorised representative products Authorised representative actors View details

2019-nCoV Neutralizing Antibody Detection Kit (Fluorescence Immunochromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521003182
Basic UDI-DI: B-06974521003182
Reference: SUPF054025
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:34

Manufacturer products Authorised representative products Authorised representative actors View details

ONE STEP Malaria P.F/Pan Tri-line Rapid Test (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001959
Basic UDI-DI: B-06974521001959
Reference: SUPG018025-1
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details

ONE STEP Malaria P.F/Pan Tri-line Rapid Test (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001942
Basic UDI-DI: B-06974521001942
Reference: SUPG018025
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details