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135 device results listed.

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TaqPath™ COVID 19, Flu A, Flu B, RSV Select Positive Control

IVD Class BIVDR 2017/746Not intended for EU marketKitProfessional testingReagent

Manufacturer: Life Technologies Corporation; Thermo Fisher Life Sciences
Manufacturer SRN: US-MF-000026189
UDI-DI: 10190302019071
Basic UDI-DI: 0190302A56125SA
Reference: 963611 (A56125)
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: -
Authorised representative: Life Technologies Europe B.V.
Last updated: 29.06.2026 10:50

Manufacturer products Authorised representative products Authorised representative actors View details

TaqPath™ COVID 19, Flu A, Flu B, RSV Select Negative Control

IVD Class BIVDR 2017/746Not intended for EU marketKitProfessional testingReagent

Manufacturer: Life Technologies Corporation; Thermo Fisher Life Sciences
Manufacturer SRN: US-MF-000026189
UDI-DI: 10190302019088
Basic UDI-DI: 0190302A56125SA
Reference: 963610 (A56125)
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: -
Authorised representative: Life Technologies Europe B.V.
Last updated: 29.06.2026 10:50

Manufacturer products Authorised representative products Authorised representative actors View details

TaqPath™ 1-Step Select Master Mix (No ROX)

IVD Class BIVDR 2017/746Not intended for EU marketKitProfessional testingReagent

Manufacturer: Life Technologies Corporation; Thermo Fisher Life Sciences
Manufacturer SRN: US-MF-000026189
UDI-DI: 10190302019095
Basic UDI-DI: 0190302A56125SA
Reference: A56520 (A56125)
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: -
Authorised representative: Life Technologies Europe B.V.
Last updated: 29.06.2026 10:50

Manufacturer products Authorised representative products Authorised representative actors View details

06955792731349

SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731349
Basic UDI-DI: B-06955792731349
Reference: S3113E-24-P
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731332
Basic UDI-DI: B-06955792731332
Reference: S3113E-48
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731325
Basic UDI-DI: B-06955792731325
Reference: S3113E-24
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

06955792730526

SARS-CoV-2/InFluA/InFluB Rapid Antigen Test (Immunochromatography Assay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792730526
Basic UDI-DI: B-06955792730526
Reference: S3121E-25
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Greece
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:28

Manufacturer products Authorised representative products Authorised representative actors View details

06955792714649

SARS-CoV-2 and Influenza A/B Virus Multiplex Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792714649
Basic UDI-DI: B-06955792714649
Reference: S3113E-12-S
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

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

Cassette

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062712350
Basic UDI-DI: 69520627J163LR
Reference: CFR1NST-10
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Safety summary (SSCP/SSP): SL-CER-CFR-6.6 · Rev. A/1
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 28.06.2026 11:22

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

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

Cassette

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062712343
Basic UDI-DI: 69520627J163LR
Reference: CFR1NST-5
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Safety summary (SSCP/SSP): SL-CER-CFR-6.6 · Rev. A/1
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 28.06.2026 11:22

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

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

Cassette

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062712336
Basic UDI-DI: 69520627J163LR
Reference: CFR1NST-2
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Safety summary (SSCP/SSP): SL-CER-CFR-6.6 · Rev. A/1
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 28.06.2026 11:22

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

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

Cassette

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062712329
Basic UDI-DI: 69520627J163LR
Reference: CFR1NST-1
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Safety summary (SSCP/SSP): SL-CER-CFR-6.6 · Rev. A/1
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 28.06.2026 11:22

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

2019-nCoV and Influenza A/B Combo Antigen Test Kit

25 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293581764
Basic UDI-DI: 697518250G1183036
Reference: G11830
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 19:26

Manufacturer products Authorised representative products Authorised representative actors View details

2019-nCoV/Influenza A+B/RSV Antigen Combo Rapid Test Kit

25 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293580781
Basic UDI-DI: 697518250E118042B
Reference: E11804
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 19:24

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A/B Antigen Determination Kit (Fluorescence Immunochromatographic Assay)

25 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle useSterile

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293580620
Basic UDI-DI: 697518250P118046S
Reference: P11804
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 19:23

Manufacturer products Authorised representative products Authorised representative actors View details