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EUDAMED Device Search

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

Last updated

03.08.2026 22:01

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1000+ device results listed.

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IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020140546
Basic UDI-DI: 6936020120BRB
Reference: HCG10-01-10t
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 19.07.2026 07:56

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020140553
Basic UDI-DI: 6936020120BRB
Reference: HCG10-02-2t
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 19.07.2026 07:56

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020140560
Basic UDI-DI: 6936020120BRB
Reference: HCG10-02-10t
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 19.07.2026 07:56

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020140577
Basic UDI-DI: 6936020120BRB
Reference: HCG10-03-2t
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 19.07.2026 07:56

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020140584
Basic UDI-DI: 6936020120BRB
Reference: HCG10-03-5t
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 19.07.2026 07:56

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020140591
Basic UDI-DI: 69360201208J
Reference: HCG-01-10t
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 19.07.2026 07:56

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020140607
Basic UDI-DI: 69360201208J
Reference: HCG-02-2t
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 19.07.2026 07:56

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020140614
Basic UDI-DI: 69360201208J
Reference: HCG-02-10t
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 19.07.2026 07:56

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020140621
Basic UDI-DI: 69360201208J
Reference: HCG-03-2t
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 19.07.2026 07:56

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020140638
Basic UDI-DI: 69360201208J
Reference: HCG-03-5t
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 19.07.2026 07:56

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020141000
Basic UDI-DI: 6936020120BRB
Reference: HCG10-PP-01-2t
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 19.07.2026 07:56

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020141017
Basic UDI-DI: 6936020120BRB
Reference: HCG10-PP-03-1t
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 19.07.2026 07:56

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Quantitative Test Kit (Time-Resolved FIA)

FIHBA-402a-DR10, FIHBA-402a-DR10LH, FIHBA-402a-DR10HG, FIHBA-402a-DR, FIHBA-402a-DRLH, FIHBA-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: 06950996003940
Basic UDI-DI: 69509960FIHBA-402a-DRES
Reference: FIHBA-402a-DR10
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Germany
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 13:49

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

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

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)

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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