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

ONE STEP Malaria P.F/P. V 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: 06974521001935
Basic UDI-DI: B-06974521001935
Reference: SUPG017025-1
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/P. V Tri-line Rapid Test (Colloidal Gold)

ONE STEP Malaria P.F/P. V 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: 06974521001928
Basic UDI-DI: B-06974521001928
Reference: SUPG017025
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) Rapid Test (Colloidal Gold)

ONE STEP Malaria (P.F) Rapid Test (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001911
Basic UDI-DI: B-06974521001911
Reference: SUPG016025-1
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) Rapid Test (Colloidal Gold)

ONE STEP Malaria (P.F) Rapid Test (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001904
Basic UDI-DI: B-06974521001904
Reference: SUPG016025
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 Dengue NS1 Ag Rapid Test (Colloidal Gold)

ONE STEP Dengue NS1 Ag Rapid Test (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001898
Basic UDI-DI: B-06974521001898
Reference: SUPG020025-1
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:31

Manufacturer products Authorised representative products Authorised representative actors View details

ONE STEP Dengue NS1 Ag Rapid Test (Colloidal Gold)

ONE STEP Dengue NS1 Ag Rapid Test (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001881
Basic UDI-DI: B-06974521001881
Reference: SUPG020025
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:31

Manufacturer products Authorised representative products Authorised representative actors View details

ONE STEP Anti-TP Rapid Test (Colloidal Gold)

ONE STEP Anti-TP Rapid Test (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001850
Basic UDI-DI: B-06974521001850
Reference: SUPG007025-1
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:31

Manufacturer products Authorised representative products Authorised representative actors View details

ONE STEP Anti-TP Rapid Test (Colloidal Gold)

ONE STEP Anti-TP Rapid Test (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001843
Basic UDI-DI: B-06974521001843
Reference: SUPG007025
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:31

Manufacturer products Authorised representative products Authorised representative actors View details

ONE STEP Anti-Dengue IgG/IgM Tri-line Rapid Test (Colloidal Gold)

ONE STEP Anti-Dengue IgG/IgM 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: 06974521001836
Basic UDI-DI: B-06974521001836
Reference: SUPG019025-1
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:31

Manufacturer products Authorised representative products Authorised representative actors View details

ONE STEP Anti-Dengue IgG/IgM Tri-line Rapid Test (Colloidal Gold)

ONE STEP Anti-Dengue IgG/IgM 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: 06974521001829
Basic UDI-DI: B-06974521001829
Reference: SUPG019025
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:31

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus（MPxV）Antigen Rapid Detection Kit （Immunochromatography Assay）

Monkeypox Virus（MPxV）Antigen 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: 06974521001812
Basic UDI-DI: B-06974521001812
Reference: SUPL030025
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 19:31

Manufacturer products Authorised representative products Authorised representative actors View details

InFluA/InFluB Ag Rapid Test (Immunochromatography Assay)

InFluA/InFluB Ag Rapid Test (Immunochromatography Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001805
Basic UDI-DI: B-06974521001805
Reference: SUPL012025
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:31

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Ag+Flu A/Flu B Rapid Test (Immunochromatography Assay)

COVID-19 Ag+Flu A/Flu B Rapid Test (Immunochromatography Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001782
Basic UDI-DI: B-06974521001782
Reference: SUPL027025
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:31

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovims (ADV) Antigen Rapid Test (Immunochromatographic Assay)

Adenovims (ADV) 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: 06974521001768
Basic UDI-DI: B-06974521001768
Reference: SUPL023025
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:31

Manufacturer products Authorised representative products Authorised representative actors View details

2019-nCoV Antigen Saliva Rapid Test (Immunochromatography Assay)

2019-nCoV Antigen Saliva Rapid Test (Immunochromatography Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001751
Basic UDI-DI: B-06974521001751
Reference: SUPL019025
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:31

Manufacturer products Authorised representative products Authorised representative actors View details

2019-nCoV Antigen Rapid Test (Immunochromatography Assay)

2019-nCoV Antigen Rapid Test (Immunochromatography Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001744
Basic UDI-DI: B-06974521001744
Reference: SUPL010025
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:31

Manufacturer products Authorised representative products Authorised representative actors View details

2019-nCoV Antigen Rapid Test (Immunochromatography Assay)

2019-nCoV Antigen Rapid Test (Immunochromatography Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001737
Basic UDI-DI: B-06974521001737
Reference: SUPL010005
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:31

Manufacturer products Authorised representative products Authorised representative actors View details

2019-nCoV Antigen Rapid Test (Immunochromatography Assay)

2019-nCoV Antigen Rapid Test (Immunochromatography Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001720
Basic UDI-DI: B-06974521001720
Reference: SUPL010003
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:31

Manufacturer products Authorised representative products Authorised representative actors View details

2019-nCoV Antigen Rapid Test (Immunochromatography Assay)

2019-nCoV Antigen Rapid Test (Immunochromatography Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001713
Basic UDI-DI: B-06974521001713
Reference: SUPL010001
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:31

Manufacturer products Authorised representative products Authorised representative actors View details

2019-nCoV Antigen Rapid Test (Immunochromatography Assay)

2019-nCoV Antigen Rapid Test (Immunochromatography Assay)

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001706
Basic UDI-DI: B-06974521001706
Reference: SUPL010005
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:31

Manufacturer products Authorised representative products Authorised representative actors View details