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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

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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

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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

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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

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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

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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

Hantavirus IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCHV(IgM)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHV(IgM)-402aVU
Basic UDI-DI: B-GCHV(IgM)-402aVU
Reference: GCHV(IgM)-402a
EMDN: W0105040614
EMDN description: HANTAVIRUS / BUNYAVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

Hantavirus IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCHV(IgM)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCHV(IgM)-402aHGY5
Basic UDI-DI: B-GCHV(IgM)-402aHGY5
Reference: GCHV(IgM)-402a
EMDN: W0105040614
EMDN description: HANTAVIRUS / BUNYAVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

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

GCHV(IgG/IgM)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHV(IgG/IgM)-402aLS
Basic UDI-DI: B-GCHV(IgG/IgM)-402aLS
Reference: GCHV(IgG/IgM)-402a
EMDN: W0105040614
EMDN description: HANTAVIRUS / BUNYAVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

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

GCHV(IgG/IgM)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCHV(IgG/IgM)-402aHGXA
Basic UDI-DI: B-GCHV(IgG/IgM)-402aHGXA
Reference: GCHV(IgG/IgM)-402a
EMDN: W0105040614
EMDN description: HANTAVIRUS / BUNYAVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

EV71 IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCEV71(IgM)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCEV71(IgM)-402a5W
Basic UDI-DI: B-GCEV71(IgM)-402a5W
Reference: GCEV71(IgM)-402a
EMDN: W0105040602
EMDN description: ENTEROVIRUS
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

EV71 IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCEV71(IgM)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCEV71(IgM)-402aHGH9
Basic UDI-DI: B-GCEV71(IgM)-402aHGH9
Reference: GCEV71(IgM)-402a
EMDN: W0105040602
EMDN description: ENTEROVIRUS
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

EV71 IgM Rapid Test Cassette (Serum/Plasma)

GCEV71(IgM)-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCEV71(IgM)-302aHGGU
Basic UDI-DI: B-GCEV71(IgM)-302aHGGU
Reference: GCEV71(IgM)-302a
EMDN: W0105040602
EMDN description: ENTEROVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details