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341 device results listed.

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COVID-19 & Influenza A+B & RSV & ADV & HMPV Antigen Combo Test Kit (LFA)

Cassette

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062712367
Basic UDI-DI: 69520627J161LM
Reference: CFRAH1NST-1
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Safety summary (SSCP/SSP): SL-CER-CFRAH-6.6 · Rev. A1
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 31.07.2026 20:22

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

res4plex direct RT-PCR

Ax, Bx, Cx

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: FRIZ Biochem GmbH
Manufacturer SRN: DE-MF-000017533
UDI-DI: 04260753890167
Basic UDI-DI: 426075389fbc107U6
Reference: FBC107-Bx
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 05:22

Manufacturer products View details

res4plex direct RT-PCR

Ax, Bx, Cx

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: FRIZ Biochem GmbH
Manufacturer SRN: DE-MF-000017533
UDI-DI: 04260753890150
Basic UDI-DI: 426075389fbc107U6
Reference: FBC107
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 02:14

Manufacturer products View details

HSV1&2 VZV R-GENE®

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026605162
Basic UDI-DI: 357302BUDI000595U8
Reference: 69-014B
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:55

Manufacturer products View details

SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ISIR-R535J4
Basic UDI-DI: B-ISIR-R535J4
Reference: ISIR-R535
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 02:33

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ISIC-525JD
Basic UDI-DI: B-ISIC-525JD
Reference: ISIC-525
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 02:33

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2/InfluenzaA+B/RSV/Adenovirus/M. pneumoniae Antigen Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IRT-R555P9
Basic UDI-DI: B-IRT-R555P9
Reference: IRT-R555
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 02:33

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IRT-R545P6
Basic UDI-DI: B-IRT-R545P6
Reference: IRT-R545
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 02:33

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 and Influenza A+B Antigen Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ICIC-R5252E
Basic UDI-DI: B-ICIC-R5252E
Reference: ICIC-R525
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 02:33

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus / RSV / Influenza A+B Combo Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IARI-R5358J
Basic UDI-DI: B-IARI-R5358J
Reference: IARI-R535
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 02:33

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Antigen/Influenza A+B Combo Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-CIC-525KC
Basic UDI-DI: B-FI-CIC-525KC
Reference: FI-CIC-525
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 02:30

Manufacturer products Authorised representative products Authorised representative actors View details

ChainFor™

Dengue/Chikungunya Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595034965
Basic UDI-DI: 868511580PCR83JQ
Reference: CFP83P25
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 29.07.2026 09:48

Manufacturer products View details

LyoSens™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595035580
Basic UDI-DI: 868511580PCR83JQ
Reference: LYO83WS24
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 29.07.2026 09:09

Manufacturer products View details

LyoSens™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115809223
Basic UDI-DI: 868511580PCR83JQ
Reference: LYO83WS48
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 29.07.2026 09:09

Manufacturer products View details

LyoSens™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115809261
Basic UDI-DI: 868511580PCR83JQ
Reference: LYO83WS96
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 29.07.2026 09:09

Manufacturer products View details

ChainFor™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595034972
Basic UDI-DI: 868511580PCR83JQ
Reference: CFP83P50
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 29.07.2026 09:09

Manufacturer products View details

ChainFor™

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595034989
Basic UDI-DI: 868511580PCR83JQ
Reference: CPF83P100
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 29.07.2026 09:09

Manufacturer products View details

RSV/Influenza A+B Combo Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IRIC-R525BB
Basic UDI-DI: B-IRIC-R525BB
Reference: IRIC-R525
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 28.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

RSV/Influenza A+B Combo Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IRIC-525HU
Basic UDI-DI: B-IRIC-525HU
Reference: IRIC-525
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Belgium
Authorised representative: MedNet EC-REP GmbH
Last updated: 28.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

VIASURE Herpes virus 1, Herpes virus 2 & Varicella Zoster Virus 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: 08435440228974
Basic UDI-DI: 84354402_MDXIMMUN_HHZ7D
Reference: VS-HHZ196TE
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: -
Last updated: 27.07.2026 05:08

Manufacturer products View details