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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

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

Allplex™ GI-Parasite Assay

IVD Class BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240100950
Basic UDI-DI: 924010GI97030FV
Reference: GI9703X
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 21.09.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ PneumoBacter Assay

IVD Class CIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101766
Basic UDI-DI: 924010PB10176EF
Reference: PB10176X
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 21.09.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ PneumoBacter Assay

IVD Class CIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101759
Basic UDI-DI: 924010PB10176EF
Reference: PB10175Y
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 21.09.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ GI-Parasite Assay

IVD Class BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240100943
Basic UDI-DI: 924010GI97030FV
Reference: GI9703Y
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 21.09.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ PneumoBacter Assay

IVD Class CIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101858
Basic UDI-DI: 924010PB10176EF
Reference: PB10185Z
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 21.09.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ GI-Parasite Assay

IVD Class BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240102022
Basic UDI-DI: 924010GI97030FV
Reference: GI10202Z
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 21.09.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ GI-Helminth(I) Assay

IVD Class BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101919
Basic UDI-DI: 924010GI10191CD
Reference: GI10191X
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 21.09.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ GI-Helminth(I) Assay

IVD Class BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101902
Basic UDI-DI: 924010GI10191CD
Reference: GI10190Y
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 21.09.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

Allplex™ GI-Helminth(I) Assay

IVD Class BIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Seegene, Inc.
Manufacturer SRN: KR-MF-000022275
UDI-DI: 08809240101896
Basic UDI-DI: 924010GI10191CD
Reference: GI10189Z
EMDN: W0105070504
EMDN description: GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 21.09.2026 21:32

Manufacturer products Authorised representative products Authorised representative actors 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

VIASURE N. gonorrhoeae, C. trachomatis & M. genitalium 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: 08435440258483
Basic UDI-DI: 84354402_MDXSEXUAL_NMTP2
Reference: VS-NMT101L
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 12.08.2026 23:33

Manufacturer products View details