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341 device results listed.

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TRUPCR® TORCH Panel Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304965
Basic UDI-DI: 89080153043B1271L7
Reference: 3B1272
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: Wellkang Ltd
Last updated: 29.06.2026 11:20

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® TORCH Panel Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304989
Basic UDI-DI: 89080153043B1271L7
Reference: 3B1271
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: Wellkang Ltd
Last updated: 29.06.2026 11:20

Manufacturer products Authorised representative products Authorised representative actors View details

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

06955792731905

Adenovirus 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: 06955792731905
Basic UDI-DI: B-06955792731905
Reference: S3335E-48
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

06955792731899

Adenovirus 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: 06955792731899
Basic UDI-DI: B-06955792731899
Reference: S3335E-24
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:32

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

Akso SARS-CoV-2/FluA/FluB Real-time RT-PCR Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414751871
Basic UDI-DI: 695441479706KS
Reference: RT6005
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

Akso SARS-CoV-2/FluA/FluB Real-time RT-PCR Kit

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414751864
Basic UDI-DI: 695441479706KS
Reference: RT6005
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:30

Manufacturer products Authorised representative products Authorised representative actors View details

BIOSYNEX AMPLIQUICK Fecal Virology

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532679915936
Basic UDI-DI: 353267F00189P9B
Reference: 3150047_SEC02
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 28.06.2026 11:40

Manufacturer products View details

BIOSYNEX AMPLIQUICK Fecal Virology

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532679915943
Basic UDI-DI: 353267F00189P9B
Reference: 3150047_BLK96
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 28.06.2026 11:40

Manufacturer products 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