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

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

Respiratory syncytial virus ( RSV ) Antigen Rapid Test (Fluorescence Immunochromatographic Assay)

Respiratory syncytial virus ( RSV ) 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: 06974521005698
Basic UDI-DI: B-06974521005698
Reference: SUPF062025
EMDN: W0105099002
EMDN description: RSV - RT & POC
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

HPIV Antigen Rapid Test (Fluorescence Immunochromatographic Assay)

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)

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)

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

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)

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

Respiratory syncytial virus ( RSV ) Antigen Rapid Test (Immunochromatography Assay)

Respiratory syncytial virus ( RSV ) 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: 06974521001966
Basic UDI-DI: B-06974521001966
Reference: SUPL022025
EMDN: W0105099002
EMDN description: RSV - RT & POC
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)

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)

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

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