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727 device results listed.

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NT-proBNP Quantitative Test Kit (Time-Resolved FIA)

IVD Class CIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996052214
Basic UDI-DI: 69509960FDBNP-402a-DRQU
Reference: FDBNP-402a-DRHG
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: -
Safety summary (SSCP/SSP): CEDR-FDBNP-402a-11.1-OG · Rev. 2.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 18.07.2026 13:47

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

cTnI/CK-MB/Myo Quantitative Test Kit (Time-Resolved FIA)

IVD Class CIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996061698
Basic UDI-DI: 69509960FDCAR-T402a-DRQ4
Reference: FDCAR-T402a-DRLH
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: -
Safety summary (SSCP/SSP): CEDR-FDCAR-T402a-11-OG · Rev. 4.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 18.07.2026 13:47

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

NT-proBNP Quantitative Test Kit (Time-Resolved FIA)

IVD Class CIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996063463
Basic UDI-DI: 69509960FDBNP-402a-DRQU
Reference: FDBNP-402a-DR10LH
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: -
Safety summary (SSCP/SSP): CEDR-FDBNP-402a-11.1-OG · Rev. 2.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 18.07.2026 13:47

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

NT-proBNP Quantitative Test Kit (Time-Resolved FIA)

IVD Class CIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996076586
Basic UDI-DI: 69509960FDBNP-402a-DRQU
Reference: FDBNP-402a-DR10HG
EMDN: W0102160704
EMDN description: BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: -
Safety summary (SSCP/SSP): CEDR-FDBNP-402a-11.1-OG · Rev. 2.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 18.07.2026 13:47

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

FOB/Transferrin/H. pylori Combo Rapid Test Device (Feces)

GEFTH-T625a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GEFTH-T625aOGT8
Basic UDI-DI: B-GEFTH-T625aOGT8
Reference: GEFTH-T625a
EMDN: W0105070599
EMDN description: MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 23:41

Manufacturer products Authorised representative products Authorised representative actors View details

Human Metapneumovirus (HMPV) Ag Rapid Test

GCHMPV-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHMPV-502aOGU3
Basic UDI-DI: B-GCHMPV-502aOGU3
Reference: GCHMPV-502a
EMDN: W0105040617
EMDN description: HUMAN METAPNEUMOVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 23:40

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A (H5) Ag Rapid Test Cassette (Swab)

GCFLU(AH5)-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFLU(AH5)-502aOGKU
Basic UDI-DI: B-GCFLU(AH5)-502aOGKU
Reference: GCFLU(AH5)-502a
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 23:40

Manufacturer products Authorised representative products Authorised representative actors View details

Flu A Ag Rapid Test Cassette (Swab)

GCFLU(A)-U502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCFLU(A)-U502aOG5L
Basic UDI-DI: B-GCFLU(A)-U502aOG5L
Reference: GCFLU(A)-U502a
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 23:40

Manufacturer products Authorised representative products Authorised representative actors View details

Bordetella Pertussis Antigen Rapid Test Kit (Colloidal Gold)

GCBP-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCBP-502aOGKF
Basic UDI-DI: B-GCBP-502aOGKF
Reference: GCBP-502a
EMDN: W0105011707
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 23:40

Manufacturer products Authorised representative products Authorised representative actors View details

Carcinoembryonic Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma)

GECEA-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GECEA-402aOGJW
Basic UDI-DI: B-GECEA-402aOGJW
Reference: GECEA-402a
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 07:02

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin Semi-Quantitative Rapid Test Cassette (Whole Blood/Serum/Plasma)

GDPCT-T402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GDPCT-T402aOGST
Basic UDI-DI: B-GDPCT-T402aOGST
Reference: GDPCT-T402a
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 07:02

Manufacturer products Authorised representative products Authorised representative actors View details

C-Reactive Protein Semi-Quantitative Rapid Test Cassette (Whole Blood/Serum/Plasma)

GDCRP-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GDCRP-402aOG4A
Basic UDI-DI: B-GDCRP-402aOG4A
Reference: GDCRP-402a
EMDN: W0102160601
EMDN description: C-REACTIVE PROTEIN - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 07:02

Manufacturer products Authorised representative products Authorised representative actors View details

Trichomonas Ag Rapid Test Cassette (Swab)

GCTV-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCTV-502aOG42
Basic UDI-DI: B-GCTV-502aOG42
Reference: GCTV-502a
EMDN: W0105050210
EMDN description: TRICHOMONAS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 07:02

Manufacturer products Authorised representative products Authorised representative actors View details

CK-MB Rapid Test Cassette (Whole Blood/Serum/Plasma)

GDCKM-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GDCKM-402aOGVD
Basic UDI-DI: B-GDCKM-402aOGVD
Reference: GDCKM-402a
EMDN: W0102160701
EMDN description: CREATINE KINASE - MB MASS - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 07:02

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid COVID-19 (Antigen) Self-Test

GCCOV-502a-H2OGE

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCOV-502a-H2OGEEW
Basic UDI-DI: B-GCCOV-502a-H2OGEEW
Reference: GCCOV-502a-H2OGE
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 05:03

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Multi-Drug Screen Test Cassette (Urine)

GBDUA-1X5

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBDUA-1X5OGYA
Basic UDI-DI: B-GBDUA-1X5OGYA
Reference: GBDUA-1X5
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: 17.07.2026 05:03

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Multi-Drug Screen Test Cassette (Urine)

GBDUA-1X5-ALC

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBDUA-1X5-ALCOGRR
Basic UDI-DI: B-GBDUA-1X5-ALCOGRR
Reference: GBDUA-1X5-ALC
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: 17.07.2026 05:03

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Multi-Drug Screen Test Cassette (Urine)

GBDOA-1X5

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBDOA-1X5OGUQ
Basic UDI-DI: B-GBDOA-1X5OGUQ
Reference: GBDOA-1X5
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: 17.07.2026 05:03

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Multi-Drug Screen Test Cassette (Urine)

GBDOA-1X5-ALC

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBDOA-1X5-ALCOGJT
Basic UDI-DI: B-GBDOA-1X5-ALCOGJT
Reference: GBDOA-1X5-ALC
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: 17.07.2026 05:03

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Alcohol Test Strip

GBALC-101a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GBALC-101aOGJY
Basic UDI-DI: B-GBALC-101aOGJY
Reference: GBALC-101a
EMDN: W0102090207
EMDN description: ETHANOL (ALCOHOL)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 05:03

Manufacturer products Authorised representative products Authorised representative actors View details