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436 device results listed.

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LyoSens™

Atypical CAP Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115804921
Basic UDI-DI: 868511580PCR129GT
Reference: LYO129WS24
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 22.09.2026 09:56

Manufacturer products View details

LyoSens™

IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115804969
Basic UDI-DI: 868511580PCR129GT
Reference: LYO129WS48
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 09:56

Manufacturer products View details

LyoSens™

LYO129WS96

IVD Class CIVDDOn the marketCompanion diagnosticsInstrumentKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115805003
Basic UDI-DI: 868511580PCR129GT
Reference: LYO129WS96
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 09:56

Manufacturer products View details

ChainFor™

IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214525987
Basic UDI-DI: 868511580PCR129GT
Reference: CFP129P25
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 09:56

Manufacturer products View details

ChainFor™

IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214525994
Basic UDI-DI: 868511580PCR129GT
Reference: CFP129P50
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 09:56

Manufacturer products View details

ChainFor™

IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685214526007
Basic UDI-DI: 868511580PCR129GT
Reference: CFP129P100
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 09:56

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™ 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™ 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

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

NamuPlex™

GNT-2013-1

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: SML Genetree Co., Ltd.
Manufacturer SRN: KR-MF-000034755
UDI-DI: 08800087901014
Basic UDI-DI: 88000879017SD
Reference: GNT-2013-1
EMDN: W0105070503
EMDN description: RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: Obelis s.a.
Last updated: 11.08.2026 22:11

Manufacturer products Authorised representative products Authorised representative actors View details

VIASURE Respiratory Viral Panel I Real Time PCR Detection Kit