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21 device results listed.

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β-hCG Quantitative Test Kit (Time-Resolved FIA)

FAHCG-402a-DR10, FDHCG-402a-DR10LH, FDHCG-402a-DR10HG, FAHCG-402a-DR, FDHCG-402a-DRLH, FDHCG-402a-DRHG

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

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996003926
Basic UDI-DI: 69509960FAHCG-402a-DRAR
Reference: FAHCG-402a-DR10
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 18.07.2026 13:49

Manufacturer products Authorised representative products Authorised representative actors View details

25-OH-VD Quantitative Test Kit (Time-Resolved FIA)

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

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

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996003902
Basic UDI-DI: 69509960FIVD-402a-DRZ9
Reference: FIVD-402a-DR10
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 18.07.2026 13:49

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI Quantitative Test Kit (Time-Resolved FIA)

FDTRO-402b-DR10, FDTRO-402b-DR10LH, FDTRO-402b-DR10HG, FDTRO-402b-DR, FDTRO-402b-DRLH, FDTRO-402b-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: 06950996003889
Basic UDI-DI: 69509960FDTRO-402b-DRDH
Reference: FDTRO-402b-DR10
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Germany
Safety summary (SSCP/SSP): CEDR-FDTRO-402b-11.1-OG · Rev. 4.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 18.07.2026 13:49

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

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

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

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

FDCAR-T402a-DR10, FDCAR-T402a-DR10LH, FDCAR-T402a-DR10HG, FDCAR-T402a-DR, FDCAR-T402a-DRLH, FDCAR-T402a-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: 06950996003865
Basic UDI-DI: 69509960FDCAR-T402a-DRQ4
Reference: FDCAR-T402a-DR10
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Germany
Safety summary (SSCP/SSP): CEDR-FDCAR-T402a-11-OG · Rev. 4.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 18.07.2026 13:49

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

TSH Quantitative Test Kit (Time-Resolved FIA)

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

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

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996003841
Basic UDI-DI: 69509960FKTSH-402a-DRH9
Reference: FKTSH-402a-DR10
EMDN: W0102160903
EMDN description: THYROID-STIMULATING HORMONE - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 18.07.2026 13:48

Manufacturer products Authorised representative products Authorised representative actors View details

CRP Quantitative Test Kit (Time-Resolved FIA)

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

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

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996003780
Basic UDI-DI: 69509960FDWCR-402a-DR4R
Reference: FDWCR-402a-DR10
EMDN: W0102160601
EMDN description: C-REACTIVE PROTEIN - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 18.07.2026 13:48

Manufacturer products Authorised representative products Authorised representative actors View details

CRP Quantitative Test Kit (Time-Resolved FIA)

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

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996003797
Basic UDI-DI: 69509960FDWCR-402a-DR4R
Reference: FDWCR-402a-DR
EMDN: W0102160601
EMDN description: C-REACTIVE PROTEIN - RT & POC
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 18.07.2026 13:47

Manufacturer products Authorised representative products Authorised representative actors 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: 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

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

TSH Quantitative Test Kit (Time-Resolved FIA)

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

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996003858
Basic UDI-DI: 69509960FKTSH-402a-DRH9
Reference: FKTSH-402a-DR
EMDN: W0102160903
EMDN description: THYROID-STIMULATING HORMONE - RT & POC
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 18.07.2026 13:47

Manufacturer products Authorised representative products Authorised representative actors 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: 06950996003872
Basic UDI-DI: 69509960FDCAR-T402a-DRQ4
Reference: FDCAR-T402a-DR
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

cTnI 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: 06950996003896
Basic UDI-DI: 69509960FDTRO-402b-DRDH
Reference: FDTRO-402b-DR
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: -
Safety summary (SSCP/SSP): CEDR-FDTRO-402b-11.1-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

25-OH-VD Quantitative Test Kit (Time-Resolved FIA)

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

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996003919
Basic UDI-DI: 69509960FIVD-402a-DRZ9
Reference: FIVD-402a-DR
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 18.07.2026 13:47

Manufacturer products Authorised representative products Authorised representative actors View details

β-hCG Quantitative Test Kit (Time-Resolved FIA)

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

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996003933
Basic UDI-DI: 69509960FAHCG-402a-DRAR
Reference: FAHCG-402a-DR
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 18.07.2026 13:47

Manufacturer products Authorised representative products Authorised representative actors View details

TSH Quantitative Test Kit (Time-Resolved FIA)

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

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996013130
Basic UDI-DI: 69509960FKTSH-402a-DRH9
Reference: FKTSH-402a-DRHG
EMDN: W0102160903
EMDN description: THYROID-STIMULATING HORMONE - RT & POC
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 18.07.2026 13:47

Manufacturer products Authorised representative products Authorised representative actors 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: 06950996037464
Basic UDI-DI: 69509960FDCAR-T402a-DRQ4
Reference: FDCAR-T402a-DR10LH
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: 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

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: 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