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SARS-CoV-2/FluA/FluB/RSV Test

Cov2P4-10

IVD generalIVDDOn the marketInstrumentKitProfessional testingReagentSingle use

Manufacturer: FlashDx Shenzhen Inc
Manufacturer SRN: CN-MF-000025748
UDI-DI: D-Cov2P4-10HND5
Basic UDI-DI: B-Cov2P4-10HND5
Reference: Cov2P4-10
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 13.07.2026 14:14

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Test

CoV2-20

IVD generalIVDDOn the marketInstrumentKitProfessional testingReagentSingle use

Manufacturer: FlashDx Shenzhen Inc
Manufacturer SRN: CN-MF-000025748
UDI-DI: D-CoV2-207D
Basic UDI-DI: B-CoV2-207D
Reference: CoV2-20
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 13.07.2026 14:14

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Test

CoV2-10

IVD generalIVDDOn the marketInstrumentKitProfessional testingReagentSingle use

Manufacturer: FlashDx Shenzhen Inc
Manufacturer SRN: CN-MF-000025748
UDI-DI: D-CoV2-107A
Basic UDI-DI: B-CoV2-107A
Reference: CoV2-10
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 13.07.2026 14:14

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

CRE Test

CRE-P5-10

IVD generalIVDDOn the marketInstrumentKitProfessional testingReagentSingle use

Manufacturer: FlashDx Shenzhen Inc
Manufacturer SRN: CN-MF-000025748
UDI-DI: D-CRE-P5-10Y6
Basic UDI-DI: B-CRE-P5-10Y6
Reference: CRE-P5-10
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 13.07.2026 07:20

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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)

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))

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

Neisseria Gonorrhoeae Antigen 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-CNMF000054349FK002FP
Basic UDI-DI: B-CNMF000054349FK002FP
Reference: FK002
EMDN: W0105070203
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
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

Bacterial vaginosis 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-CNMF000054349CR028GR
Basic UDI-DI: B-CNMF000054349CR028GR
Reference: CR028
EMDN: W0105070203
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 13.07.2026 07:07

Manufacturer products Authorised representative products Authorised representative actors View details

Trichomonas/Candida 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-CNMF000054349CR027GP
Basic UDI-DI: B-CNMF000054349CR027GP
Reference: CR027
EMDN: W0105070203
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 13.07.2026 07:07

Manufacturer products Authorised representative products Authorised representative actors View details

Trichomonas Vaginalis Antigen 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-CNMF000054349CR026GM
Basic UDI-DI: B-CNMF000054349CR026GM
Reference: CR026
EMDN: W0105070203
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 13.07.2026 07:07

Manufacturer products Authorised representative products Authorised representative actors View details

Candida Albicans Antigen 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-CNMF000054349CR025GK
Basic UDI-DI: B-CNMF000054349CR025GK
Reference: CR025
EMDN: W0105070203
EMDN description: GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 13.07.2026 07:07

Manufacturer products Authorised representative products Authorised representative actors View details

D-CN-MF-000041344S7

ACAB01,ACAB02

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000041344
UDI-DI: D-CN-MF-000041344S7
Basic UDI-DI: B-CN-MF-000041344S7
Reference: ACAB01,ACAB02
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 05:09

Manufacturer products Authorised representative products Authorised representative actors View details

GenomEra HSV 1/2, VZV + EV Assay Kit

CDX-170

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: D-CDX-170-01-40UND
Basic UDI-DI: B-CDX-170-01-40UND
Reference: CDX-170-01-40
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

Manufacturer products View details

GenomEra HSV 1/2, VZV + EV Assay Kit

CDX-170

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-170-01-40P3
Basic UDI-DI: B-CDX-170-01-40P3
Reference: CDX-170-01-40
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

Manufacturer products View details

GenomEra HSV 1/2, VZV + EV Assay Kit

CDX-170

IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Uniogen Oy
Manufacturer SRN: FI-MF-000032341
UDI-DI: D-CDX-170-01-20UN3
Basic UDI-DI: B-CDX-170-01-20UN3
Reference: CDX-170-01-20
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

Manufacturer products View details

GenomEra HSV 1/2, VZV + EV Assay Kit

CDX-170

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Abacus Diagnostica Oy
Manufacturer SRN: FI-MF-000024114
UDI-DI: D-CDX-170-01-20NV
Basic UDI-DI: B-CDX-170-01-20NV
Reference: CDX-170-01-20
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Finland
Authorised representative: -
Last updated: 13.07.2026 03:59

Manufacturer products View details