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Last updated

23.09.2026 17:50

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3578239

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Active filter:EMDN:W01050703

371 device results listed.

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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 productsView 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 productsAuthorised representative productsAuthorised representative actorsView details
Cowingene Respiratory Pathogen Panel Pro Detection Kit

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 productsAuthorised representative productsAuthorised representative actorsView details
Cowingene SARS-CoV-2 & Influenza A/B Detection Kit

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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView details
SARS-CoV-2 + Flu A&B Ag Test Kit (Time-Resolved FIA)

FCFC-T502a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN
CN-MF-000017965
UDI-DI
D-FCFC-T502aTH
Basic UDI-DI
B-FCFC-T502aTH
Reference
FCFC-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 productsAuthorised representative productsAuthorised representative actorsView details
SARS-CoV-2 + Flu A&B Ag Test Kit (Time-Resolved FIA)

FCFC-T502a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
Healgen Scientific Limited Liability Company
Manufacturer SRN
US-MF-000018839
UDI-DI
D-FCFC-T502aHGRR
Basic UDI-DI
B-FCFC-T502aHGRR
Reference
FCFC-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 productsAuthorised representative productsAuthorised representative actorsView details
COVID-19 & Influenza A+B & RSV & ADV & HMPV Antigen Combo Test Kit (LFA)

-

IVD Class CNot specifiedOn the marketAnimal tissuesKitSelf testingSingle use
Manufacturer
ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN
CN-MF-000018785
UDI-DI
06952062712374
Basic UDI-DI
69520627J161LM
Reference
CFRAH1NST-2
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
13.07.2026 11:18
Manufacturer productsAuthorised representative productsAuthorised representative actorsOpen in EUDAMEDView details