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D-GN7103121H3

SARS-CoV-2 Real time Fluorescent PCR Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-GN7103121H3
Basic UDI-DI: B-GN7103121H3
Reference: GN7103121
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-GN7101121GM

SARS-CoV-2 Real time Fluorescent PCR Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-GN7101121GM
Basic UDI-DI: B-GN7101121GM
Reference: GN7101121
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM 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-GKPD156XR
Basic UDI-DI: B-GKPD156XR
Reference: GKPD156
EMDN: W0105040611
EMDN description: DENGUE VIRUS
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

ADV 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-GKPD152XH
Basic UDI-DI: B-GKPD152XH
Reference: GKPD152
EMDN: W0105040601
EMDN description: ADENOVIRUS
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

Zika 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-GKPD120X4
Basic UDI-DI: B-GKPD120X4
Reference: GKPD120
EMDN: W0105040630
EMDN description: ZIKA VIRUS
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

Chikungunya Virus IgG/IgM Antibody and Antigen Combo 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-GKPD119XK
Basic UDI-DI: B-GKPD119XK
Reference: GKPD119
EMDN: W0105040625
EMDN description: CHIKUNGUNYA VIRUS
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

Chikungunya 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-GKPD118XH
Basic UDI-DI: B-GKPD118XH
Reference: GKPD118
EMDN: W0105040625
EMDN description: CHIKUNGUNYA VIRUS
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

Chikungunya 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-GKPD117XF
Basic UDI-DI: B-GKPD117XF
Reference: GKPD117
EMDN: W0105040625
EMDN description: CHIKUNGUNYA VIRUS
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

Zika NS1 Ag Rapid Test Cassette(Whole blood/Serum/Plasma)

GCZIK(NS1)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCZIK(NS1)-402aHGK4
Basic UDI-DI: B-GCZIK(NS1)-402aHGK4
Reference: GCZIK(NS1)-402a
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

Zika NS1 Ag Rapid Test Cassette(Whole blood/Serum/Plasma)

GCZIK(NS1)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCZIK(NS1)-402aCD
Basic UDI-DI: B-GCZIK(NS1)-402aCD
Reference: GCZIK(NS1)-402a
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

Zika IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma)

GCZIK(IgG/IgM)-T402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCZIK(IgG/IgM)-T402aHDG
Basic UDI-DI: B-GCZIK(IgG/IgM)-T402aHDG
Reference: GCZIK(IgG/IgM)-T402a
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

Zika IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma)

GCZIK(IgG/IgM)-T402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCZIK(IgG/IgM)-T402a3U
Basic UDI-DI: B-GCZIK(IgG/IgM)-T402a3U
Reference: GCZIK(IgG/IgM)-T402a
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

Zika IgG Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCZIK(IgG)-402b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCZIK(IgG)-402bUW
Basic UDI-DI: B-GCZIK(IgG)-402bUW
Reference: GCZIK(IgG)-402b
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

Zika IgG Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCZIK(IgG)-402b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCZIK(IgG)-402bHGB7
Basic UDI-DI: B-GCZIK(IgG)-402bHGB7
Reference: GCZIK(IgG)-402b
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus and Adenovirus Combo Rapid Test Cassette (Feces)

GCROA/ADE-602a

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCROA/ADE-602aRF
Basic UDI-DI: B-GCROA/ADE-602aRF
Reference: GCROA/ADE-602a
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Austria
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus and Adenovirus Combo Rapid Test Cassette (Feces)

GCROA/ADE-602a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCROA/ADE-602aHGLL
Basic UDI-DI: B-GCROA/ADE-602aHGLL
Reference: GCROA/ADE-602a
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
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

Rotavirus Rapid Test Cassette (Feces)

GCROA-602a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCROA-602aHG5Z
Basic UDI-DI: B-GCROA-602aHG5Z
Reference: GCROA-602a
EMDN: W0105040606
EMDN description: ROTAVIRUS
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

Rotavirus Rapid Test Cassette (Feces)

GCROA-602Ca

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCROA-602CaHGBB
Basic UDI-DI: B-GCROA-602CaHGBB
Reference: GCROA-602Ca
EMDN: W0105040606
EMDN description: ROTAVIRUS
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

Norovirus Antigen Rapid Test Cassette (Feces)

GCNOR-602a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCNOR-602aHGCG
Basic UDI-DI: B-GCNOR-602aHGCG
Reference: GCNOR-602a
EMDN: W0105040616
EMDN description: NOROVIRUS
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

Norovirus Antigen Rapid Test Cassette (Feces)

GCNOR-602a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCNOR-602a9E
Basic UDI-DI: B-GCNOR-602a9E
Reference: GCNOR-602a
EMDN: W0105040616
EMDN description: NOROVIRUS
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