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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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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

Manufacturer products Authorised representative products Authorised representative actors View details

RSV Antigen Fluorescent Rapid Test Cassette (Swab)

FCRSV-502a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FCRSV-502aHGKS
Basic UDI-DI: B-FCRSV-502aHGKS
Reference: FCRSV-502a
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details

RSV Antigen Fluorescent Rapid Test Cassette (Swab)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FCRSV-502aEE
Basic UDI-DI: B-FCRSV-502aEE
Reference: FCRSV-502a
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details

RSV Antigen Fluorescence Rapid Test Cassette (Swab)

FCRSV-502Ca

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FCRSV-502CaHGU8
Basic UDI-DI: B-FCRSV-502CaHGU8
Reference: FCRSV-502Ca
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details

RSV Antigen Fluorescence Rapid Test Cassette (Swab)

FCRSV-502Ca

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FCRSV-502CaCW
Basic UDI-DI: B-FCRSV-502CaCW
Reference: FCRSV-502Ca
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details

HPIV Antigen Rapid Test Kit (Time-Resolved FIA)

FCHPIV-502a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FCHPIV-502aHGPT
Basic UDI-DI: B-FCHPIV-502aHGPT
Reference: FCHPIV-502a
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details

HPIV Antigen Rapid Test Kit (Time-Resolved FIA)

FCHPIV-502a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FCHPIV-502a9T
Basic UDI-DI: B-FCHPIV-502a9T
Reference: FCHPIV-502a
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details

Flu A(H5) Ag Fluorescent Rapid Test Cassette (Time-Resolved FIA)

FCFLU(AH5)-502a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FCFLU(AH5)-502aHGHC
Basic UDI-DI: B-FCFLU(AH5)-502aHGHC
Reference: FCFLU(AH5)-502a
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details

Flu A(H5) Ag Fluorescent Rapid Test Cassette (Time-Resolved FIA)

FCFLU(AH5)-502a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FCFLU(AH5)-502aGT
Basic UDI-DI: B-FCFLU(AH5)-502aGT
Reference: FCFLU(AH5)-502a
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details

Flu A Ag Fluorescent Rapid Test Cassette (Time-Resolved FIA)

FCFLU(A)-502a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FCFLU(A)-502aVJ
Basic UDI-DI: B-FCFLU(A)-502aVJ
Reference: FCFLU(A)-502a
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details

Flu A Ag Fluorescent Rapid Test Cassette (Time-Resolved FIA)

FCFLU(A)-502a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FCFLU(A)-502aHG7D
Basic UDI-DI: B-FCFLU(A)-502aHG7D
Reference: FCFLU(A)-502a
EMDN: W0105040604
EMDN description: INFLUENZA & PARA INFLUENZA
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:18

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus Antigen Fluorescence Rapid Test Cassette (Swab)

FCADE-502a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FCADE-502aMC
Basic UDI-DI: B-FCADE-502aMC
Reference: FCADE-502a
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:17

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus Antigen Fluorescence Rapid Test Cassette (Swab)

FCADE-502a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FCADE-502aHGFE
Basic UDI-DI: B-FCADE-502aHGFE
Reference: FCADE-502a
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:17

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus Antigen Fluorescence Rapid Test Cassette (Swab)

FCADE-502Ca

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FCADE-502CaHGHU
Basic UDI-DI: B-FCADE-502CaHGHU
Reference: FCADE-502Ca
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:17

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus Antigen Fluorescence Rapid Test Cassette (Swab)

FCADE-502Ca

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FCADE-502CaEN
Basic UDI-DI: B-FCADE-502CaEN
Reference: FCADE-502Ca
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:17

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4492014JC
Basic UDI-DI: B-EIM4492014JC
Reference: EIM4492014
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details