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D-IIN-501SC

IIN-501

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: D-IIN-501SC
Basic UDI-DI: B-IIN-501SC
Reference: IIN-501
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 01:09

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 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-IDEC-R425YM
Basic UDI-DI: B-IDEC-R425YM
Reference: IDEC-R425
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
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

Dengue NS1 Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD155XP
Basic UDI-DI: B-GKPD155XP
Reference: GKPD155
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

RSV Ag Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD151XF
Basic UDI-DI: B-GKPD151XF
Reference: GKPD151
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A/B Ag Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD148XS
Basic UDI-DI: B-GKPD148XS
Reference: GKPD148
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

Mpox 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-GKPD124XC
Basic UDI-DI: B-GKPD124XC
Reference: GKPD124
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
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

Mpox 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-GKPD123XA
Basic UDI-DI: B-GKPD123XA
Reference: GKPD123
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
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

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

Dengue IgG/IgM/NS1 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-GKPD115XB
Basic UDI-DI: B-GKPD115XB
Reference: GKPD115
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
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

Respiratory Syncytial Virus (RSV) 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-GKPD102X2
Basic UDI-DI: B-GKPD102X2
Reference: GKPD102
EMDN: W0105099002
EMDN description: RSV - RT & POC
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

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

RSV Antigen Rapid Test Cassette (Swab)

GCRSV-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCRSV-502aHGLX
Basic UDI-DI: B-GCRSV-502aHGLX
Reference: GCRSV-502a
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details