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157 device results listed.

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Influenza Virus Subtype N6 Real Time PCR Kit

JC10134NW-50T

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-JC10134NW-50TQS
Basic UDI-DI: B-JC10134NW-50TQS
Reference: JC10134NW-50T
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 03:22

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza Virus Subtype N6 Real Time PCR Kit

JC10134NW-25T

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-JC10134NW-25TQS
Basic UDI-DI: B-JC10134NW-25TQS
Reference: JC10134NW-25T
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 03:22

Manufacturer products Authorised representative products Authorised representative actors View details

VIASURE Flu Typing II Real Time PCR Detection Kit

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

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440222927
Basic UDI-DI: 84354402_MDXRESP_HXNZ2
Reference: VS-HXN101L
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 10.07.2026 22:52

Manufacturer products View details

Truenat Influenza A/B

601200025

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908020139446
Basic UDI-DI: B-08908020139446
Reference: 601200025
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:30

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat Influenza A/B

601200050

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989668
Basic UDI-DI: B-08908007989668
Reference: 601200050
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat Influenza A/B

601200020

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989651
Basic UDI-DI: B-08908007989651
Reference: 601200020
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Truenat Influenza A/B

601200005

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Molbio Diagnostics Limited
Manufacturer SRN: IN-MF-000028386
UDI-DI: 08908007989644
Basic UDI-DI: B-08908007989644
Reference: 601200005, 601200020, 601200025, 601200050
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 10.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

08885019710711

300107

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019710711
Basic UDI-DI: B-08885019710711
Reference: 300107
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 10.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors View details

08885019710117

300108

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: AITbiotech Pte Ltd
Manufacturer SRN: SG-MF-000003510
UDI-DI: 08885019710117
Basic UDI-DI: B-08885019710117
Reference: 300108
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 10.07.2026 17:20

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SA Influenza A/B & 2009 H1N1 RT-PCR Test

111267

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013953954
Basic UDI-DI: B-08885013953954
Reference: 111267
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:18

Manufacturer products Authorised representative products Authorised representative actors View details

Sentosa SA Influenza A/B & RSV RT-PCR Test (4x24)

300145

IVD generalIVDDOn the marketKitMicrobial substancesReagentSingle use

Manufacturer: Vela Operations Singapore Pte. Ltd.
Manufacturer SRN: SG-MF-000025684
UDI-DI: 08885013953107
Basic UDI-DI: B-08885013953107
Reference: 300145
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Germany
Authorised representative: Vela Diagnostics Germany GmbH
Last updated: 10.07.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

08800204300201

RADI FAST Influenza A/B Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KH Medical Co., Ltd.
Manufacturer SRN: KR-MF-000017883
UDI-DI: 08800204300201
Basic UDI-DI: B-08800204300201
Reference: RV011F
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 08:14

Manufacturer products Authorised representative products Authorised representative actors View details

PowerChek™ Parainfluenza Virus 1/2/3 Real-time PCR Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: KogeneBiotech Co., Ltd.
Manufacturer SRN: KR-MF-000045858
UDI-DI: 08800056362037
Basic UDI-DI: B-08800056362037
Reference: R6200T
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 01:32

Manufacturer products Authorised representative products Authorised representative actors View details

PowerChek™ Influenza B (Victoria & Yamagata) Real-time PCR Kit Ver.1.1

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: KogeneBiotech Co., Ltd.
Manufacturer SRN: KR-MF-000045858
UDI-DI: 08800056330005
Basic UDI-DI: B-08800056330005
Reference: R3013TA
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 10.07.2026 01:32

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorion

Fluorion Influenza A/B QLP 1.0 Real-Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.
Manufacturer SRN: TR-MF-000023054
UDI-DI: 08698898740973
Basic UDI-DI: B-08698898740973
Reference: M1410102
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 15:00

Manufacturer products View details

LyoSens FLU B qPCR Kit

LYO147WS96

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115808219
Basic UDI-DI: B-08685115808219
Reference: LYO147
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:23

Manufacturer products View details

LyoSens FLU A qPCR Kit

LYO146WS96

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115808097
Basic UDI-DI: B-08685115808097
Reference: LYO146
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:23

Manufacturer products View details

LyoSens FLU A + B qPCR Kit

LYO37WS96

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998274616
Basic UDI-DI: B-08684998274616
Reference: LYO37
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:21

Manufacturer products View details

RevoDx Influenza A-H3 qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387215282
Basic UDI-DI: B-08684387215282
Reference: IP202531-100
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:04

Manufacturer products View details

RevoDx Influenza A-H3 qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387215275
Basic UDI-DI: B-08684387215275
Reference: IP202531-25
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 02:04

Manufacturer products View details