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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

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

HbA1c 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: 06950996003964
Basic UDI-DI: 69509960FIHBA-402a-DRES
Reference: FIHBA-402a-DR
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: -
Safety summary (SSCP/SSP): CEDR-FIHBA-402a-11.1-OG · Rev. 3.0
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: 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

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

Fecal Occult Blood Rapid Test Device (Feces)

GEFB-606b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GEFB-606bHGGL
Basic UDI-DI: B-GEFB-606bHGGL
Reference: GEFB-606b
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - 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

hCG One Step Pregnancy Test

hCG-103a

IVD self-testing devicesIVDDOn the marketKitNear-patient testingSelf testingSingle use

Manufacturer: Sejoy Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000008447
UDI-DI: 06939663910712
Basic UDI-DI: B-06939663910712
Reference: hCG-103a
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 23:07

Manufacturer products Authorised representative products Authorised representative actors View details

FSH Rapid Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983101127
Basic UDI-DI: B-06936983101127
Reference: FFS-103H
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 17.07.2026 23:07

Manufacturer products Authorised representative products Authorised representative actors View details

LH Ovulation Rapid Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983100526
Basic UDI-DI: B-06936983100526
Reference: FLH-103H
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 17.07.2026 23:07

Manufacturer products Authorised representative products Authorised representative actors View details

Pregnancy (hCG) Enhanced Sensitivity Rapid Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983100519
Basic UDI-DI: B-06936983100519
Reference: FHC-U103H
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 17.07.2026 23:07

Manufacturer products Authorised representative products Authorised representative actors View details

Pregnancy (hCG) Enhanced Sensitivity Rapid Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 05056668200974
Basic UDI-DI: B-05056668200974
Reference: FHC-U103H
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 17.07.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Fecal Occult Blood Test Card

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSelf testingSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963718013
Basic UDI-DI: 692196371613J5
Reference: 1M01C4-B1-CE
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Netherlands
Safety summary (SSCP/SSP): RR1M01040-R · Rev. 6.0
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 07:34

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

Rapid Fecal Occult Blood Test Card

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSelf testingSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963718020
Basic UDI-DI: 692196371613J5
Reference: 1M01C4-B5-CE
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: -
Safety summary (SSCP/SSP): RR1M01040-R · Rev. 6.0
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 07:31

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

Rapid Fecal Occult Blood Test Card

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSelf testingSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963718037
Basic UDI-DI: 692196371613J5
Reference: 1M01C4-B25-CE
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: -
Safety summary (SSCP/SSP): RR1M01040-R · Rev. 6.0
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 07:31

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