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

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6 device results listed.

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

FDBNP-402a-DR10, FDBNP-402a-DR, FDBNP-402a-DR10LH, FDBNP-402a-DRLH, FDBNP-402a-DR10HG, FDBNP-402a-DRHG

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
06950996003827
Basic UDI-DI
69509960FDBNP-402a-DRQU
Reference
FDBNP-402a-DR10
EMDN
W0102160704
EMDN description
BNP / PROBNP - RT & POC (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country
Germany
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 13:49
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
06950996003834
Basic UDI-DI
69509960FDBNP-402a-DRQU
Reference
FDBNP-402a-DR
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
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
06950996040969
Basic UDI-DI
69509960FDBNP-402a-DRQU
Reference
FDBNP-402a-DRLH
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
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
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
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