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120 device results listed.

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Influenza A/B & RSV RT-PCR Test Kit

IRP53Na

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IRP53NHJ
Basic UDI-DI: B-IRP53NHJ
Reference: IRP53Na
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 & Influenza A/B RT-PCR Test Kit

IID53Na

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IID53NBT
Basic UDI-DI: B-IID53NBT
Reference: IID53Na
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Detection Kit for Influenza A Virus, Influenza B Virus and Respiratory Syncytial Virus RNA (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870385
Basic UDI-DI: B-06974081870385
Reference: RTI001
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: 05.08.2026 14:43

Manufacturer products Authorised representative products Authorised representative actors View details

06955792732179

Influenza A/B Virus and Respiratory Syncytial 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: 06955792732179
Basic UDI-DI: B-06955792732179
Reference: S3336E-48
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:57

Manufacturer products Authorised representative products Authorised representative actors View details

06955792732162

Influenza A/B Virus and Respiratory Syncytial 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: 06955792732162
Basic UDI-DI: B-06955792732162
Reference: S3336E-24
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:57

Manufacturer products Authorised representative products Authorised representative actors View details

VitaPCR Flu/RSV Assay

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Manufacturer SRN: TW-MF-000023414
UDI-DI: 04719878570084
Basic UDI-DI: B-04719878570084
Reference: PCRAE0106
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors View details

RT-PCR Respiratory panel 1: SARS-CoV-2/Flu/RSV

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIANA Biotechnologies, a.s
Manufacturer SRN: CZ-MF-000022346
UDI-DI: 08594210150089
Basic UDI-DI: B-08594210150089
Reference: DB-1250-100rxns
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Czechia
Authorised representative: -
Last updated: 18.07.2026 10:18

Manufacturer products View details

D-69509960ACOV03RF4U

ACOV03-AOG48E; ACOV03-AOG96E; ACOV03D-AOG48E; ACOV03D-AOG96E

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960ACOV03RF4U
Basic UDI-DI: B-69509960ACOV03RF4U
Reference: ACOV03-AOG48E; ACOV03-AOG96E; ACOV03D-AOG48E; ACOV03D-AOG96E
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: 17.07.2026 03:52

Manufacturer products Authorised representative products Authorised representative actors View details

D-69509960101A0227EYZSNY

101A0227EY

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-69509960101A0227EYZSNY
Basic UDI-DI: B-69509960101A0227EYZSNY
Reference: 101A0227EY
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: 17.07.2026 03:52

Manufacturer products Authorised representative products Authorised representative actors View details

Xpert®

Xpert® Xpress Flu/RSV

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Cepheid
Manufacturer SRN: US-MF-000010979
UDI-DI: 07332940002329
Basic UDI-DI: B-07332940002329
Reference: XPRSFLU/RSV-CE-10
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Netherlands
Authorised representative: Cepheid AB
Last updated: 16.07.2026 19:55

Manufacturer products Authorised representative products Authorised representative actors View details

Alinity m

Alinity m Resp-4-Plex

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

Manufacturer: Abbott Molecular Inc.
Manufacturer SRN: US-MF-000017776
UDI-DI: 00884999052109
Basic UDI-DI: 0884999AMN0067WU
Reference: 09N79-092
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Abbott GmbH
Last updated: 16.07.2026 07:24

Manufacturer products Authorised representative products Authorised representative actors View details

Alinity m

ALINITY M RESP-4-PLEX

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

Manufacturer: Abbott Molecular Inc.
Manufacturer SRN: US-MF-000017776
UDI-DI: 00884999049338
Basic UDI-DI: 0884999AMN0979YG
Reference: 09N79-090
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Abbott GmbH
Last updated: 16.07.2026 07:23

Manufacturer products Authorised representative products Authorised representative actors View details

cobas® eplex respiratory pathogen panel 3 (RP3)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: GenMark Diagnostics
Manufacturer SRN: US-MF-000010772
UDI-DI: 00857167005399
Basic UDI-DI: 085716700510246944001PN
Reference: 10246944001
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:41

Manufacturer products Authorised representative products Authorised representative actors View details

D-W0105070304EM

ACOV03,ACOV03D

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000041344
UDI-DI: D-W0105070304EM
Basic UDI-DI: B-W0105070304EM
Reference: ACOV03,ACOV03D
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: 15.07.2026 13:28

Manufacturer products Authorised representative products Authorised representative actors View details

VivaDiag Influenza A+B/RSV Test Kit (FIA)

VID111

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID111EJ
Basic UDI-DI: B-VID111EJ
Reference: VID111-01-011
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

geneMAP

geneMAP Respiratory Viral Panel 3 (2019-nCoV, Inf A/B),100T

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000028405
UDI-DI: D-TRMF000028405RV3RT100FP
Basic UDI-DI: B-TRMF000028405RV3RT100FP
Reference: RV3-RT100
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 15.07.2026 11:23

Manufacturer products View details

geneMAP

geneMAP Respiratory Viral Panel 2 (2019-nCoV, Inf A/B, RSV A/B),100T

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000028405
UDI-DI: D-TRMF000028405RV2RT100FA
Basic UDI-DI: B-TRMF000028405RV2RT100FA
Reference: RV2-RT100
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 15.07.2026 11:23

Manufacturer products View details

geneMAP

geneMAP Respiratory Master Panel, 50T

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000028405
UDI-DI: D-TRMF000028405RVMRT50W3
Basic UDI-DI: B-TRMF000028405RVMRT50W3
Reference: RVM-RT50
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 15.07.2026 11:23

Manufacturer products View details

D-TD-HNKX-CED-574J

Influenza A/B & RSV Antigen Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-574J
Basic UDI-DI: B-TD-HNKX-CED-574J
Reference: /
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: 15.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene Respiratory Pathogen Panel Pro Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-RP2602CC
Basic UDI-DI: B-RP2602CC
Reference: RP26021V, RP26021Y, RP26021V-1, RP26021Y-1, RP26022U, RP26022X, RP26022U-1, RP26022X-1
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 05:28

Manufacturer products Authorised representative products Authorised representative actors View details