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753 device results listed.

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COVID-19 Antigen Rapid Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ISCOVu005G
Basic UDI-DI: B-ISCOVu005G
Reference: ISCOVu002-A001; ISCOVu002-A005; ISCOVu002-A025; ISCOVu002-B001; ISCOVu002-B005; ISCOVu002-B025
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Hungary
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:42

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue/Zika/Chikungunya 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-IDZC-R445C3
Basic UDI-DI: B-IDZC-R445C3
Reference: IDZC-R445
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue/Chikungunya/Zika 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-IDCZ-R43594
Basic UDI-DI: B-IDCZ-R43594
Reference: IDCZ-R435
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Antigen Rapid Test

cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ICOV05FD
Basic UDI-DI: B-ICOV05FD
Reference: ICOV5002-B001;ICOV5002-B005;ICOV5002-B025
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

Cryptosporidium and Giardia lamblia 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-ICGC-R625ZE
Basic UDI-DI: B-ICGC-R625ZE
Reference: ICGC-R625
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:04

Manufacturer products Authorised representative products Authorised representative actors View details

HSV IgG/IgM Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-HSV-D02aN9
Basic UDI-DI: B-HSV-D02aN9
Reference: HSV-D02a
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 00:57

Manufacturer products Authorised representative products Authorised representative actors View details

Yellow Fever Virus IgG/IgM Antibody Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD121X6
Basic UDI-DI: B-GKPD121X6
Reference: GKPD121
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

Nipah Virus IgG/IgM Ab Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD113X7
Basic UDI-DI: B-GKPD113X7
Reference: GKPD113
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

Nipah Virus Ag Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD112X5
Basic UDI-DI: B-GKPD112X5
Reference: GKPD112
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

Mumps Virus IgM Ab Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD101WY
Basic UDI-DI: B-GKPD101WY
Reference: GKPD101
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus IgM Ab Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD100WW
Basic UDI-DI: B-GKPD100WW
Reference: GKPD100
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19/Flu A&B/RSV/Adeno/HPIV/HMPV/RhV/M. pneumoniae Ag Combo Rapid Test Cassette (Swab)

GCRESA-T555a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCRESA-T555aNB
Basic UDI-DI: B-GCRESA-T555aNB
Reference: GCRESA-T555a
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:29

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 testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFR(A)-T502aMC
Basic UDI-DI: B-GCFR(A)-T502aMC
Reference: GCFR(A)-T502a
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - 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&B/RSV Ag Combo Rapid Test Cassette (Swab)

GCFR-T502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFR-T502a4G
Basic UDI-DI: B-GCFR-T502a4G
Reference: GCFR-T502a
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - 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

COVID-19/Flu A/Flu B/RSV/ADV/M.P Ag Combo Rapid Test Cassette (Swab)

GCFCRAMP-T535a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFCRAMP-T535aDE
Basic UDI-DI: B-GCFCRAMP-T535aDE
Reference: GCFCRAMP-T535a
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)

GCFCRA-T525a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFCRA-T525a8X
Basic UDI-DI: B-GCFCRA-T525a8X
Reference: GCFCRA-T525a
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

Flu, COVID-19, RSV & Adeno Ag Combo Test Cassette (Swab)

GCFCRA-545a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFCRA-545aWP
Basic UDI-DI: B-GCFCRA-545aWP
Reference: GCFCRA-545a
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19/Flu A&B/RSV Ag Combo Rapid Test Cassette (Swab)

GCFCR-T525a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFCR-T525a3T
Basic UDI-DI: B-GCFCR-T525a3T
Reference: GCFCR-T525a
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 /Flu A&B /RSV Ag Combo Rapid Test Cassette (Swab)

GCFCR-T525a-NN

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFCR-T525a-NNNG
Basic UDI-DI: B-GCFCR-T525a-NNNG
Reference: GCFCR-T525a-NN
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 /Flu A&B /RSV Ag Combo Rapid Test Cassette (Swab)

GCFCR-T525a-NN

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCFCR-T525a-NNHGR9
Basic UDI-DI: B-GCFCR-T525a-NNHGR9
Reference: GCFCR-T525a-NN
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details