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Arbovirus ViraChip IgM Deca Kit

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: EVIRABCMDK1
Basic UDI-DI: ++EVIRArbovirusKit5C
Reference: V-ABCMDK
EMDN: W01050799
EMDN description: MULTIPLE VIRUSES - OTHER
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 03:16

Manufacturer products View details

LyoSens™

LYO02WS96

IVD Class BIVDDOn the marketCompanion diagnosticsInstrumentKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998276382
Basic UDI-DI: 868499827PCR02XD
Reference: LYO02WS96
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 02:45

Manufacturer products View details

05430004263739

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Poly Diagnostics
Manufacturer SRN: LU-MF-000042647
UDI-DI: 05430004263739
Basic UDI-DI: 5430004263PD102FV
Reference: PD102
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 02:30

Manufacturer products View details

05407013452171

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Poly Diagnostics
Manufacturer SRN: LU-MF-000042647
UDI-DI: 05407013452171
Basic UDI-DI: 5430004263PD102FV
Reference: PD102D
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 02:30

Manufacturer products View details

05407013452188

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Poly Diagnostics
Manufacturer SRN: LU-MF-000042647
UDI-DI: 05407013452188
Basic UDI-DI: 5430004263PD102FV
Reference: PD102D
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 02:30

Manufacturer products View details

Allplex™ RP-Virus(I) Assay

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

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240105160
Basic UDI-DI: 924010RP10516M9
Reference: RP10516X
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 22.09.2026 01:58

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ RP-Virus(II) Assay

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

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240105191
Basic UDI-DI: 924010RP10519MF
Reference: RP10519X
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 22.09.2026 01:58

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ GI-EB plus Screening Assay

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240102817
Basic UDI-DI: 924010GI10280CD
Reference: GI10281Z
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 22.09.2026 01:57

Manufacturer products Authorised representative products Authorised representative actors View details

BIOFIRE® FILMARRAY® Pneumonia Panel plus

IVD Class DIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BioFire Diagnostics, LLC
Manufacturer SRN: US-MF-000003311
UDI-DI: 00815381020321
Basic UDI-DI: 357302BUDI002137TL
Reference: RFIT-ASY-0142
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Safety summary (SSCP/SSP): BFR0002-7033 · Rev. 1
Authorised representative: bioMérieux SA
Last updated: 22.09.2026 00:53

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

mariPOC® Respi test plate

IVD Class AIVDR 2017/746No longer on the marketAnimal tissuesMicrobial substancesProfessional testing

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: 06430080370009
Basic UDI-DI: 6430080371114MJ9
Reference: 1114M
EMDN: W01050799
EMDN description: MULTIPLE VIRUSES - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 21.09.2026 23:23

Manufacturer products View details

RapidFor™

IL-6 (FIA)

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595038314
Basic UDI-DI: 868354825VMPO34EPP5
Reference: VMPO34ED
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 21.09.2026 22:43

Manufacturer products View details

Arbovirus ViraChip IgM Positive Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingMicrobial substancesProfessional testingReagent

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: EVIRABCMPK1
Basic UDI-DI: ++EVIRArbovirusControlYX
Reference: V-ABCMPK
EMDN: W01050799
EMDN description: MULTIPLE VIRUSES - OTHER
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 21:48

Manufacturer products View details

Arbovirus ViraChip IgG,A,M Negative Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingMicrobial substancesProfessional testingReagent

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: EVIRABCPNK1
Basic UDI-DI: ++EVIRArbovirusControlYX
Reference: V-ABCPNK
EMDN: W01050799
EMDN description: MULTIPLE VIRUSES - OTHER
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 21:48

Manufacturer products View details

Arbovirus ViraChip IgM Antigen Coated Wells

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Viramed Biotech AG
Manufacturer SRN: DE-MF-000020368
UDI-DI: EVIRABCMAC1
Basic UDI-DI: ++EVIRArbovirusAB5F
Reference: V-ABCMAC
EMDN: W01050799
EMDN description: MULTIPLE VIRUSES - OTHER
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 21:45

Manufacturer products View details

RIDA®Plex Respiratory Pathogens B 16 well Step 1

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006678
Basic UDI-DI: B-09343044006678
Reference: 20612S
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 21.09.2026 21:21

Manufacturer products Authorised representative products Authorised representative actors View details

RIDA®Plex Respiratory Pathogens B 16 well Step 2

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AusDiagnostics Pty Ltd
Manufacturer SRN: AU-MF-000020558
UDI-DI: 09343044006661
Basic UDI-DI: B-09343044006661
Reference: 20612P
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: R-Biopharm AG
Last updated: 21.09.2026 21:21

Manufacturer products Authorised representative products Authorised representative actors View details

mariPOC® Quick Flu+ test plate

IVD Class AIVDR 2017/746No longer on 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: 21.09.2026 21:00

Manufacturer products View details

Influenza A/B and RSV RT-qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IIR-P51(AT)US
Basic UDI-DI: B-IIR-P51(AT)US
Reference: IIR-P51
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 18:07

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2, Influenza A/B and RSV RT-qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ISIR-P51(AT)HF
Basic UDI-DI: B-ISIR-P51(AT)HF
Reference: ISIR-P51
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:32

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue, Zika and Chikungunya Virus RT-qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IDZC-P30(AT)6D
Basic UDI-DI: B-IDZC-P30(AT)6D
Reference: IDZC-P30
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:28

Manufacturer products Authorised representative products Authorised representative actors View details