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23 device results listed.

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Nucleic Acid Detection Kit for Seven respiratory pathogens (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870408
Basic UDI-DI: B-06974081870408
Reference: CFPD003
EMDN: W01050799
EMDN description: MULTIPLE VIRUSES - OTHER
First on market country: Greece
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:44

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus/Adenovirus Antigen Test Kit (Colloidal Gold)

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062711575
Basic UDI-DI: B-06952062711575
Reference: RA1FE-20
EMDN: W01050799
EMDN description: MULTIPLE VIRUSES - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 16.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus/Adenovirus Antigen Test Kit (Colloidal Gold)

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062710035
Basic UDI-DI: B-06952062710035
Reference: RA1FE-25
EMDN: W01050799
EMDN description: MULTIPLE VIRUSES - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 16.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus/Adenovirus Antigen Test Kit (Colloidal Gold)

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062710028
Basic UDI-DI: B-06952062710028
Reference: RA1FE-1
EMDN: W01050799
EMDN description: MULTIPLE VIRUSES - OTHER
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 16.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2, Influenza A&B Antigen Combined Detection Kit (Immunochromatography)

20 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366471
Basic UDI-DI: B-06974849366471
Reference: HWTS-RT101B
EMDN: W01050799
EMDN description: MULTIPLE VIRUSES - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:52

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2, Influenza A&B Antigen Combined Detection Kit (Immunochromatography)

1 test/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366464
Basic UDI-DI: B-06974849366464
Reference: HWTS-RT101A
EMDN: W01050799
EMDN description: MULTIPLE VIRUSES - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:52

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-COV-2 and Influenza A/B Antigen Detection Kit (Immunochromatography)

HWTS-RT096B

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366358
Basic UDI-DI: B-06974849366358
Reference: HWTS-RT096B
EMDN: W01050799
EMDN description: MULTIPLE VIRUSES - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-COV-2 and Influenza A/B Antigen Detection Kit (Immunochromatography)

1 test/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366341
Basic UDI-DI: B-06974849366341
Reference: HWTS-RT096A
EMDN: W01050799
EMDN description: MULTIPLE VIRUSES - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-COV-2, Influenza A and Influenza B Antigen Detection Kit (Immunochromatography)

20 tests/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366334
Basic UDI-DI: B-06974849366334
Reference: HWTS-RT096B
EMDN: W01050799
EMDN description: MULTIPLE VIRUSES - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-COV-2, Influenza A and Influenza B Antigen Detection Kit (Immunochromatography)

1 test/kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849366327
Basic UDI-DI: B-06974849366327
Reference: HWTS-RT096A
EMDN: W01050799
EMDN description: MULTIPLE VIRUSES - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-Fluorescence Probing)

48 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892558
Basic UDI-DI: B-06974674892558
Reference: 18-01-0015
EMDN: W01050799
EMDN description: MULTIPLE VIRUSES - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:16

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A+B virus & 2019-nCoV (2019-nCoV orf1ab/N Gene) Diagnostic Kit (PCR-Fluorescence Probing)

48 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892541
Basic UDI-DI: B-06974674892541
Reference: 18-01-0014
EMDN: W01050799
EMDN description: MULTIPLE VIRUSES - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:16

Manufacturer products Authorised representative products Authorised representative actors View details

Rhinovirus, Respiratory Syncytial Virus & respiratory Adenovirus Diagnostic Kit (PCR-Fluorescence Probing)

48 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892534
Basic UDI-DI: B-06974674892534
Reference: 18-01-0013
EMDN: W01050799
EMDN description: MULTIPLE VIRUSES - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:16

Manufacturer products Authorised representative products Authorised representative actors View details

EnterovirusV71+Coxsackievirus A16 Combo Test

25Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303438
Basic UDI-DI: B-06974566303438
Reference: ICE-422
EMDN: W01050799
EMDN description: MULTIPLE VIRUSES - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus and Adenovirus Antigen Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566302974
Basic UDI-DI: B-06974566302974
Reference: RAD-622
EMDN: W01050799
EMDN description: MULTIPLE VIRUSES - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus Group+Adenovirus+Norovir us G1+Norovirus GII combo Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566302950
Basic UDI-DI: B-06974566302950
Reference: RAN-642
EMDN: W01050799
EMDN description: MULTIPLE VIRUSES - OTHER
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Kit for InFluA/InFluB Ag (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521003281
Basic UDI-DI: B-06974521003281
Reference: SUPF050025
EMDN: W01050799
EMDN description: MULTIPLE VIRUSES - OTHER
First on market country: Ireland
Authorised representative: QbD RepS BV
Last updated: 06.07.2026 19:36

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521001775
Basic UDI-DI: B-06974521001775
Reference: SUPL029025
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

mariPOC® Quick Flu+ test plate

IVD Class AIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testing

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: 06430080370085
Basic UDI-DI: 6430080371224MJM
Reference: 1224M
EMDN: W01050799
EMDN description: MULTIPLE VIRUSES - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:00

Manufacturer products View details