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

GCCHK(IgG/IgM)-402b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCHK(IgG/IgM)-402bHGJB
Basic UDI-DI: B-GCCHK(IgG/IgM)-402bHGJB
Reference: GCCHK(IgG/IgM)-402b
EMDN: W0105040625
EMDN description: CHIKUNGUNYA VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

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

GCCHK(IgG/IgM)-402b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCHK(IgG/IgM)-402b6J
Basic UDI-DI: B-GCCHK(IgG/IgM)-402b6J
Reference: GCCHK(IgG/IgM)-402b
EMDN: W0105040625
EMDN description: CHIKUNGUNYA VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus Rapid Test Cassette (Feces)

GCADE-602a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCADE-602aNG
Basic UDI-DI: B-GCADE-602aNG
Reference: GCADE-602a
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus Rapid Test Cassette (Feces)

GCADE-602a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCADE-602aHGGY
Basic UDI-DI: B-GCADE-602aHGGY
Reference: GCADE-602a
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus Rapid Test Cassette (Feces)

GCADE-602Ca

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCADE-602CaHGKN
Basic UDI-DI: B-GCADE-602CaHGKN
Reference: GCADE-602Ca
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus Antigen Rapid Test Cassette (Swab)

GCADE-502a

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCADE-502aN9
Basic UDI-DI: B-GCADE-502aN9
Reference: GCADE-502a
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus Antigen Rapid Test Cassette (Swab)

GCADE-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCADE-502aHGGK
Basic UDI-DI: B-GCADE-502aHGGK
Reference: GCADE-502a
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus Antigen Rapid Test Cassette (Swab)

GCADE-502Ca

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCADE-502CaHGK5
Basic UDI-DI: B-GCADE-502CaHGK5
Reference: GCADE-502Ca
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus Antigen Rapid Test Cassette (Swab)

GCADE-502Ca

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCADE-502CaFM
Basic UDI-DI: B-GCADE-502CaFM
Reference: GCADE-502Ca
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

RSV-Q Real Time PCR Kit

G2M801221

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2M801221ER
Basic UDI-DI: B-G2M801221ER
Reference: G2M801221, G2M801221R
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:44

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RSV Antigen Fluorescent Rapid Test Cassette (Swab)

FCRSV-502a