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VIASURE Herpes virus 1, Herpes virus 2 & Varicella Zoster Virus Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440212164
Basic UDI-DI: 84354402_MDXIMMUN_HHZ7D
Reference: VS-HHZ113LE
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 21.07.2026 22:49

Manufacturer products View details

VIASURE Herpes virus 1, Herpes virus 2 & Varicella Zoster Virus Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440212171
Basic UDI-DI: 84354402_MDXIMMUN_HHZ7D
Reference: VS-HHZ113HE
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 21.07.2026 22:49

Manufacturer products 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

Multi-Respiratory Antigen test (Swab)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Aceso Laboratories, Inc.
Manufacturer SRN: US-MF-000045175
UDI-DI: D-SWx5-RTC(PRO)NF
Basic UDI-DI: B-SWx5-RTC(PRO)NF
Reference: SWx5-RTC(PRO)
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 23:41

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Respiratory Antigen Test (Swab)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Aceso Laboratories, Inc.
Manufacturer SRN: US-MF-000045175
UDI-DI: D-SWx5-RTC(PLUS)DS
Basic UDI-DI: B-SWx5-RTC(PLUS)DS
Reference: SWx5-RTC(PLUS)
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 23:41

Manufacturer products Authorised representative products Authorised representative actors View details

RIDA®Plex Viral 12 well Step 2

RIDA®Plex Viral 12 well

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044007743
Basic UDI-DI: B-09343044007743
Reference: 27095P
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 17.07.2026 07:21

Manufacturer products Authorised representative products Authorised representative actors View details

RIDA®Plex Viral 12 well Step 1

RIDA®Plex Viral 12 well

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044007736
Basic UDI-DI: B-09343044007736
Reference: 27095S
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 17.07.2026 07:21

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IRTB-R555H2
Basic UDI-DI: B-IRTB-R555H2
Reference: IRTB-R555
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 05:04

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IRTA-R555GM
Basic UDI-DI: B-IRTA-R555GM
Reference: IRTA-R555
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 05:04

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IRTA-R545GJ
Basic UDI-DI: B-IRTA-R545GJ
Reference: IRTA-R545
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 05:04

Manufacturer products Authorised representative products Authorised representative actors 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

08800111716799

M10-CVFR-02

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesNear-patient testingProfessional testingSingle use

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111716799
Basic UDI-DI: 88001117IPBA01MA03WR
Reference: 11FLU30A
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:41

Manufacturer products Authorised representative products Authorised representative actors View details

res4plex direct RT-PCR

Ax, Bx, Cx

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: FRIZ Biochem GmbH
Manufacturer SRN: DE-MF-000017533
UDI-DI: 04260753890174
Basic UDI-DI: 426075389fbc107U6
Reference: FBC107-Cx
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 09:20

Manufacturer products 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

TaqPath™ COVID 19, Flu A, Flu B, RSV Select Assay

TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel

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: 10190302019064
Basic UDI-DI: 0190302A56125SA
Reference: A56430 (A56125)
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: -
Authorised representative: Life Technologies Europe B.V.
Last updated: 15.07.2026 22:50

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