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EUDAMED Device Search

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591 device results listed.

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Progesterone (PROG) Rapid Quantitative Test Kit (FIA)

Progesterone (PROG) Rapid Quantitative Test Kit (FIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521002277
Basic UDI-DI: B-06974521002277
Reference: SUPF123024
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:32

Manufacturer products Authorised representative products Authorised representative actors View details

25-Hydroxyvitamin D (25-OH-VD) Rapid Quantitative Test Kit (FIA)

25-Hydroxyvitamin D (25-OH-VD) Rapid Quantitative Test Kit (FIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521002260
Basic UDI-DI: B-06974521002260
Reference: SUPF122024
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:32

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 IgG/IgM - NS1 Combo Test (Colloidal Gold)

ONE STEP Dengue IgG/IgM - NS1 Combo Test (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001874
Basic UDI-DI: B-06974521001874
Reference: SUPG021025-1
EMDN: W0105040611
EMDN description: DENGUE VIRUS
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 IgG/IgM - NS1 Combo Test (Colloidal Gold)

ONE STEP Dengue IgG/IgM - NS1 Combo Test (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001867
Basic UDI-DI: B-06974521001867
Reference: SUPG021025
EMDN: W0105040611
EMDN description: DENGUE VIRUS
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: 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&Influenza A/B Combo Test (Immunochromatography Assay)

COVID-19 Ag&Influenza A/B Combo Test (Immunochromatography Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001799
Basic UDI-DI: B-06974521001799
Reference: SUPL028025
EMDN: W01050799
EMDN description: MULTIPLE VIRUSES - 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