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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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135 device results listed.

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Flu A&B/RSV Ag Combo Rapid Test Cassette (Swab)

GCFR-T502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCFR-T502aHG5S
Basic UDI-DI: B-GCFR-T502aHG5S
Reference: GCFR-T502a
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

Flu A/RSV Ag Combo Rapid Test Cassette (Swab)

GCFR(A)-T502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCFR(A)-T502aHGYU
Basic UDI-DI: B-GCFR(A)-T502aHGYU
Reference: GCFR(A)-T502a
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

RSV/Adenovirus Antigen Combo Fluorescence Rapid Test Cassette (Swab)

FCRA-T502a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FCRA-T502aZK
Basic UDI-DI: B-FCRA-T502aZK
Reference: FCRA-T502a
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details

RSV/Adenovirus Antigen Combo Fluorescence Rapid Test Cassette (Swab)

FCRA-T502a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FCRA-T502aHG3A
Basic UDI-DI: B-FCRA-T502aHG3A
Reference: FCRA-T502a
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A&B Ag Test Kit (Time-Resolved FIA)

FCFLU(A/B)-502Fa

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FCFLU(A/B)-502FaMA
Basic UDI-DI: B-FCFLU(A/B)-502FaMA
Reference: FCFLU(A/B)-502Fa
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A&B Ag Test Kit (Time-Resolved FIA)

FCFLU(A/B)-502Fa

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FCFLU(A/B)-502FaHGLV
Basic UDI-DI: B-FCFLU(A/B)-502FaHGLV
Reference: FCFLU(A/B)-502Fa
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 + Flu A&B Ag Test Kit (Time-Resolved FIA)

FCFC-T502a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FCFC-T502aTH
Basic UDI-DI: B-FCFC-T502aTH
Reference: FCFC-T502a
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 + Flu A&B Ag Test Kit (Time-Resolved FIA)

FCFC-T502a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FCFC-T502aHGRR
Basic UDI-DI: B-FCFC-T502aHGRR
Reference: FCFC-T502a
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 & Influenza A+B & RSV & ADV & HMPV Antigen Combo Test Kit (LFA)

-

IVD Class CNot specifiedOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062712374
Basic UDI-DI: 69520627J161LM
Reference: CFRAH1NST-2
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Safety summary (SSCP/SSP): SL-CER-CFRAH-6.6 · Rev. A1
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 13.07.2026 11:18

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

COVID-19 & Influenza A+B & RSV & ADV & HMPV Antigen Combo Test Kit (LFA)

-

IVD Class CNot specifiedOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062712381
Basic UDI-DI: 69520627J161LM
Reference: CFRAH1NST-5
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Safety summary (SSCP/SSP): SL-CER-CFRAH-6.6 · Rev. A1
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 13.07.2026 11:18

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

COVID-19 & Influenza A+B & RSV & ADV & HMPV Antigen Combo Test Kit (LFA)

-

IVD Class CNot specifiedOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062712398
Basic UDI-DI: 69520627J161LM
Reference: CFRAH1NST-10
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Safety summary (SSCP/SSP): SL-CER-CFRAH-6.6 · Rev. A1
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 13.07.2026 11:18

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

COVID-19/Influenza(A+B)/RSV Antigen Combo Rapid Test Kit(Colloidal gold method)

COVID-19/Influenza(A+B)/RSV Antigen Combo Rapid Test Kit(Colloidal gold method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000054349
UDI-DI: D-CNMF000054349RQ009MK
Basic UDI-DI: B-CNMF000054349RQ009MK
Reference: RQ009
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 13.07.2026 07:09

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19/Influenza A+B Antigen Combo Rapid Test Kit(Colloidal gold method)

COVID-19/Influenza A+B Antigen Combo Rapid Test Kit(Colloidal gold method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000054349
UDI-DI: D-CNMF000054349RQ007MF
Basic UDI-DI: B-CNMF000054349RQ007MF
Reference: RQ007
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 13.07.2026 07:09

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-COV-2 Nucleocapsid(N) Antigen Rapid Detection kit (Colloidal gold method))

SARS-COV-2 Nucleocapsid(N) Antigen Rapid Detection kit (Colloidal gold method))

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle useSterile

Manufacturer: Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000054349
UDI-DI: D-CNMF000054349RQ005MB
Basic UDI-DI: B-CNMF000054349RQ005MB
Reference: RQ005
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 13.07.2026 07:09

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2/InFluA/InFluB Antigen Rapid Test (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808155-1BE
Basic UDI-DI: B-808155-1BE
Reference: 808155-1
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:54

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Antigen Rapid Test (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-808152-1AX
Basic UDI-DI: B-808152-1AX
Reference: 808152-1
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 09:54

Manufacturer products Authorised representative products Authorised representative actors View details

TaqPath™ COVID-19, Flu A/B, RSV Control

TaqPath™ COVID-19, Flu A/B, RSV Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Life Technologies Corporation; Thermo Fisher Life Sciences
Manufacturer SRN: US-MF-000026189
UDI-DI: 10190302015707
Basic UDI-DI: B-10190302015707
Reference: 966124 (A49867)
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 11.07.2026 00:40

Manufacturer products Authorised representative products Authorised representative actors View details

TaqPath™ COVID-19, Flu A/B, RSV Assay Kit

TaqPath™ COVID-19, Flu A/B, RSV Assay Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Life Technologies Corporation; Thermo Fisher Life Sciences
Manufacturer SRN: US-MF-000026189
UDI-DI: 10190302015691
Basic UDI-DI: B-10190302015691
Reference: A49956 (A49867)
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 11.07.2026 00:40

Manufacturer products Authorised representative products Authorised representative actors View details

TaqPath™ 1-Step Multiplex Master Mix (no ROX)

TaqPath™ 1-Step Multiplex Master Mix (no ROX)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Life Technologies Corporation; Thermo Fisher Life Sciences
Manufacturer SRN: US-MF-000026189
UDI-DI: 10190302015660
Basic UDI-DI: B-10190302015660
Reference: A49971 (A49867)
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 11.07.2026 00:40

Manufacturer products Authorised representative products Authorised representative actors View details

TaqPath™ COVID-19, Flu A/B, RSV Control Dilution Buffer

TaqPath™ COVID-19, Flu A/B, RSV Control Dilution Buffer

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Life Technologies Corporation; Thermo Fisher Life Sciences
Manufacturer SRN: US-MF-000026189
UDI-DI: 10190302015516
Basic UDI-DI: B-10190302015516
Reference: A49958 (A49867)
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Netherlands
Authorised representative: Life Technologies Europe B.V.
Last updated: 11.07.2026 00:40

Manufacturer products Authorised representative products Authorised representative actors View details