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727 device results listed.

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BNP Control

FDBNA-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDBNA-PN20ZV
Basic UDI-DI: B-FDBNA-PN20ZV
Reference: FDBNA-PN20
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

BNP Quantitative Test Kit (Time-Resolved FIA)

FDBNA-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDBNA-402aS5
Basic UDI-DI: B-FDBNA-402aS5
Reference: FDBNA-402a
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

RSV Antigen FIA Control Kit

FCRSV-PN2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FCRSV-PN2PT
Basic UDI-DI: B-FCRSV-PN2PT
Reference: FCRSV-PN2
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
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

D-FCRSV-502aEE

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: 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

RSV/Adenovirus Antigen Combo Fluorescence Rapid Test Cassette (Swab)

FCRA-T502a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FCRA-T502aZK
Basic UDI-DI: B-FCRA-T502aZK
Reference: FCRA-T502a
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
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

Healgen® Gonorrhoea Fluorescent Rapid Test

FCGON-502a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FCGON-502a2H
Basic UDI-DI: B-FCGON-502a2H
Reference: FCGON-502a
EMDN: W0105010201
EMDN description: GONOCOCCAL ANTIGEN DETECTION
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

Influenza A&B Ag Test Kit (Time-Resolved FIA)

FCFLU(A/B)-502Fa

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/B)-502FaMA
Basic UDI-DI: B-FCFLU(A/B)-502FaMA
Reference: FCFLU(A/B)-502Fa
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
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

SARS-CoV-2 + Flu A&B Ag Test Kit (Time-Resolved FIA)

FCFC-T502a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FCFC-T502aTH
Basic UDI-DI: B-FCFC-T502aTH
Reference: FCFC-T502a
EMDN: W0105070399
EMDN description: MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
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

SARS-CoV-2 Ag Fluorescence 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-FCCOV-502a3D
Basic UDI-DI: B-FCCOV-502a3D
Reference: FCCOV-502a
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
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 FIA Control Kit

FCADE-PN2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FCADE-PN22U
Basic UDI-DI: B-FCADE-PN22U
Reference: FCADE-PN2
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
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: 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-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

Oral Fluid Drug Test Kit (FIA)

FBxxx-702a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FBxxx-702aWL
Basic UDI-DI: B-FBxxx-702aWL
Reference: FBxxx-702a
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
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

Hair Drug Rapid Test Kit (Time-Resolved FIA)

FBXXX-1102/FBDOA-11X5

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FBXXX-1102/FBDOA-11X529
Basic UDI-DI: B-FBXXX-1102/FBDOA-11X529
Reference: FBXXX-1102/FBDOA-11X5
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
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

Fentanyl Rapid Test Kit (Time-Resolved FIA)

FBFEN-102a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FBFEN-102aSW
Basic UDI-DI: B-FBFEN-102aSW
Reference: FBFEN-102a
EMDN: W0102090122
EMDN description: FENTANYL
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

PROG Control

FAPRO-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FAPRO-PN20FX
Basic UDI-DI: B-FAPRO-PN20FX
Reference: FAPRO-PN20
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
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