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374 device results listed.

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VivaDiag Influenza A+B/RSV Test Kit (FIA)

VID111

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID111EJ
Basic UDI-DI: B-VID111EJ
Reference: VID111-01-011
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

geneMAP

geneMAP Respiratory Viral Panel 3 (2019-nCoV, Inf A/B),100T

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000028405
UDI-DI: D-TRMF000028405RV3RT100FP
Basic UDI-DI: B-TRMF000028405RV3RT100FP
Reference: RV3-RT100
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 15.07.2026 11:23

Manufacturer products View details

geneMAP

geneMAP Respiratory Viral Panel 2 (2019-nCoV, Inf A/B, RSV A/B),100T

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000028405
UDI-DI: D-TRMF000028405RV2RT100FA
Basic UDI-DI: B-TRMF000028405RV2RT100FA
Reference: RV2-RT100
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 15.07.2026 11:23

Manufacturer products View details

geneMAP

geneMAP Respiratory Master Panel, 50T

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ
Manufacturer SRN: TR-MF-000028405
UDI-DI: D-TRMF000028405RVMRT50W3
Basic UDI-DI: B-TRMF000028405RVMRT50W3
Reference: RVM-RT50
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 15.07.2026 11:23

Manufacturer products View details

D-TD-HNKX-CED-574J

Influenza A/B & RSV Antigen Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-574J
Basic UDI-DI: B-TD-HNKX-CED-574J
Reference: /
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene Respiratory Pathogen Panel Pro Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-RP2602CC
Basic UDI-DI: B-RP2602CC
Reference: RP26021V, RP26021Y, RP26021V-1, RP26021Y-1, RP26022U, RP26022X, RP26022U-1, RP26022X-1
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 05:28

Manufacturer products Authorised representative products Authorised representative actors View details

Cowingene SARS-CoV-2 & Influenza A/B Detection Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Taizhou Cowingene Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000042619
UDI-DI: D-RP11M6
Basic UDI-DI: B-RP11M6
Reference: RP11021X, RP11022X, RP11023W
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 05:28

Manufacturer products Authorised representative products Authorised representative actors View details

InfectCheck SARS-CoV-2/RSV/FluA/FluB

SARS-CoV-2/RSV/ FluA/ FluB Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024153
UDI-DI: D-K12-RVPanel4CU
Basic UDI-DI: B-K12-RVPanel4CU
Reference: 811028/ K12-RVPanel4
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 03:36

Manufacturer products Authorised representative products Authorised representative actors View details

Zika Virus/Dengue Virus/Chikungunya Virus Real Time PCR Kit

JC30302NW-50T

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-JC30302NW-50TRB
Basic UDI-DI: B-JC30302NW-50TRB
Reference: JC30302NW-50T
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

Zika Virus/Dengue Virus/Chikungunya Virus Real Time PCR Kit

JC30302NW-25T

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-JC30302NW-25TRB
Basic UDI-DI: B-JC30302NW-25TRB
Reference: JC30302NW-25T
EMDN: W0105070302
EMDN description: OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Virus Panel (7) Real Time PCR Kit

JC150701NW-48T

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-JC150701NW-48TLQ
Basic UDI-DI: B-JC150701NW-48TLQ
Reference: JC150701NW-48T
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Virus Panel (7) Real Time PCR Kit

JC150701NW-24T

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-JC150701NW-24TL2
Basic UDI-DI: B-JC150701NW-24TL2
Reference: JC150701NW-24T
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

Flu A&B/RSV Ag Combo Rapid Test Cassette (Swab)

GCFR-T502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCFR-T502aHG5S
Basic UDI-DI: B-GCFR-T502aHG5S
Reference: GCFR-T502a
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

Flu A/RSV Ag Combo Rapid Test Cassette (Swab)

GCFR(A)-T502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCFR(A)-T502aHGYU
Basic UDI-DI: B-GCFR(A)-T502aHGYU
Reference: GCFR(A)-T502a
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

RCP-Q comprehensive Real Time PCR Kit for Respiratory

G2M803521

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2M803521FN
Basic UDI-DI: B-G2M803521FN
Reference: G2M803521,G2M803521R
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:45

Manufacturer products Authorised representative products Authorised representative actors View details

CoVFlu One Step RT PCR Kit

G2M272721

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2M272721FQ
Basic UDI-DI: B-G2M272721FQ
Reference: G2M272721,G2M272721R
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

RSV/Adenovirus Antigen Combo Fluorescence Rapid Test Cassette (Swab)

FCRA-T502a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FCRA-T502aZK
Basic UDI-DI: B-FCRA-T502aZK
Reference: FCRA-T502a
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details

RSV/Adenovirus Antigen Combo Fluorescence Rapid Test Cassette (Swab)

FCRA-T502a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FCRA-T502aHG3A
Basic UDI-DI: B-FCRA-T502aHG3A
Reference: FCRA-T502a
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A&B Ag Test Kit (Time-Resolved FIA)

FCFLU(A/B)-502Fa

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FCFLU(A/B)-502FaMA
Basic UDI-DI: B-FCFLU(A/B)-502FaMA
Reference: FCFLU(A/B)-502Fa
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A&B Ag Test Kit (Time-Resolved FIA)

FCFLU(A/B)-502Fa

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FCFLU(A/B)-502FaHGLV
Basic UDI-DI: B-FCFLU(A/B)-502FaHGLV
Reference: FCFLU(A/B)-502Fa
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details