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341 device results listed.

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BIOSYNEX AMPLIQUICK Respiratory Duplex

BIOSYNEX AMPLIQUICK Respiratory duplex

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532670102625
Basic UDI-DI: B-03532670102625
Reference: 3150076_SEC01
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:38

Manufacturer products View details

HVRe Influenza/RSV/SARS-CoV-2

Fluxergy HVRe Influenza/RSV/ SARS-CoV-2

IVD generalIVDDNo longer on the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: Fluxergy Inc.
Manufacturer SRN: US-MF-000010833
UDI-DI: 00850027856612
Basic UDI-DI: B-00850027856612
Reference: 8032
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.07.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

HVRe Influenza/RSV/SARS-CoV-2

Fluxergy HVRe Influenza/RSV/ SARS-CoV-2

IVD generalIVDDNo longer on the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: Fluxergy Inc.
Manufacturer SRN: US-MF-000010833
UDI-DI: 00850027856605
Basic UDI-DI: B-00850027856605
Reference: 8029
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.07.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

D-000041242SI003-254C

25 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Ningbo BESTest Bio-technology Co.,Ltd.
Manufacturer SRN: CN-MF-000041242
UDI-DI: D-000041242SI003-254C
Basic UDI-DI: B-000041242SI003-254C
Reference: SI003-25
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 04.07.2026 09:00

Manufacturer products Authorised representative products Authorised representative actors View details

D-000041242SI003-0546

5 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Ningbo BESTest Bio-technology Co.,Ltd.
Manufacturer SRN: CN-MF-000041242
UDI-DI: D-000041242SI003-0546
Basic UDI-DI: B-000041242SI003-0546
Reference: SI003-05
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 04.07.2026 09:00

Manufacturer products Authorised representative products Authorised representative actors View details

D-000041242SI003-013W

1 test/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Ningbo BESTest Bio-technology Co.,Ltd.
Manufacturer SRN: CN-MF-000041242
UDI-DI: D-000041242SI003-013W
Basic UDI-DI: B-000041242SI003-013W
Reference: SI003-01
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 04.07.2026 09:00

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A/B Antigen Detection Kit (Immunochromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-000012807191072QE
Basic UDI-DI: B-000012807191072QE
Reference: HWTS-RT130
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 08:59

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue Virus, Zika Virus and Chikungunya Virus Multiplex Nucleic Acid Detection Kit (Fluorescence PCR)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-0000128071570B4RE
Basic UDI-DI: B-0000128071570B4RE
Reference: HWTS-FE040
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

PlexPCR Flu/RSV/SARS-CoV-2

1.0

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224001365
Basic UDI-DI: 9352224017031BNA
Reference: 1703192
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 04.07.2026 00:07

Manufacturer products Authorised representative products Authorised representative actors View details

PlexPCR RespiVirus (610)

1.0

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: SpeeDx Pty. Ltd.
Manufacturer SRN: AU-MF-000016649
UDI-DI: 09352224000108
Basic UDI-DI: 9352224012010WA
Reference: 1201001
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 04.07.2026 00:07

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® TORCH Panel Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304958
Basic UDI-DI: 89080153043B1271L7
Reference: 3B1271/C
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:07

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® Influenza A/B & RSV with SARS-CoV-2 RT qPCR Kit

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304781
Basic UDI-DI: 89080153043B012MQ
Reference: 3B012/C
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:07

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCR® SARS-CoV-2 RT qPCR Kit

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08908015304774
Basic UDI-DI: 89080153043B304N8
Reference: 3B304
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:07

Manufacturer products Authorised representative products Authorised representative actors View details

TRUPCRÂ® Flu Panel with RSV detection Kit

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: 3B BlackBio Dx Limited
Manufacturer SRN: IN-MF-000023698
UDI-DI: 08906213930030
Basic UDI-DI: 89080153043B221N3
Reference: 3B221/C
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 03.07.2026 22:02

Manufacturer products Authorised representative products Authorised representative actors View details

Freeze-dried Six Respiratory Pathogens Nucleic Acid Detection Kit (Fluorescence PCR)

HWTS-RT177A

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849368680
Basic UDI-DI: 697484936RT177AVK
Reference: HWTS-RT177A
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:36

Manufacturer products Authorised representative products Authorised representative actors View details

RespiGUARD4plex

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

Manufacturer: APPOLON BIOTECK
Manufacturer SRN: FR-MF-000022234
UDI-DI: 03760322820072
Basic UDI-DI: 376032282DINFSCFRRK
Reference: AB0024
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 15:25

Manufacturer products View details

BIOSYNEX AMPLIQUICK Fecal Virology

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

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532679915929
Basic UDI-DI: 353267F00189P9B
Reference: 3150047_SEC01
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:27

Manufacturer products View details

Anatolia Geneworks

Bosphore Viral Infections in the Immunosuppressed Panel Kit

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.
Manufacturer SRN: TR-MF-000022487
UDI-DI: 08680018942961
Basic UDI-DI: 868001894PCRABVIP3SQ
Reference: ABVIP2
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 17:06

Manufacturer products View details

Anatolia Geneworks

Bosphore Viral Infections in the Immunosuppressed Panel Kit

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.
Manufacturer SRN: TR-MF-000022487
UDI-DI: 08680018942954
Basic UDI-DI: 868001894PCRABVIP3SQ
Reference: ABVIP1
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 17:06

Manufacturer products View details

Anatolia Geneworks

Bosphore Viral Infections in the Immunosuppressed Panel Kit

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.
Manufacturer SRN: TR-MF-000022487
UDI-DI: 08680018941353
Basic UDI-DI: 868001894PCRABVIP3SQ
Reference: ABVIP3
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 17:06

Manufacturer products View details