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01.08.2026 01:12

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112 device results listed.

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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 Influenza A qPCR Kit

LYO113WS96

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998277594
Basic UDI-DI: B-08684998277594
Reference: LYO113
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

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

RevoDx Influenza A H1N1 (pdm09) qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387215268
Basic UDI-DI: B-08684387215268
Reference: IP202512-100
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 H1N1 (pdm09) qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387215251
Basic UDI-DI: B-08684387215251
Reference: IP202512-25
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

RevoDx Parainfluenza virus 4 qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212847
Basic UDI-DI: B-08684387212847
Reference: IP202422-100
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:55

Manufacturer products View details

RevoDx Parainfluenza virus 4 qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212830
Basic UDI-DI: B-08684387212830
Reference: IP202422-25
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:55

Manufacturer products View details

RevoDx Parainfluenza virus 3 qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212823
Basic UDI-DI: B-08684387212823
Reference: IP202421-100
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:54

Manufacturer products View details

RevoDx Parainfluenza virus 3 qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212816
Basic UDI-DI: B-08684387212816
Reference: IP202421-25
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:54

Manufacturer products View details

RevoDx Parainfluenza virus 2 qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212809
Basic UDI-DI: B-08684387212809
Reference: IP202420-100
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:54

Manufacturer products View details

RevoDx Parainfluenza virus 2 qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212793
Basic UDI-DI: B-08684387212793
Reference: IP202420-25
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:54

Manufacturer products View details

RevoDx Parainfluenza virus 1 qPCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000047330
UDI-DI: 08684387212786
Basic UDI-DI: B-08684387212786
Reference: IP202419-100
EMDN: W0105040504
EMDN description: INFLUENZA & PARA INFLUENZA - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 01:54

Manufacturer products View details