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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

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

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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

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

VIASURE N. gonorrhoeae, C. trachomatis & M. genitalium Real Time PCR Detection Kit