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EUDAMED Device Search

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

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17.07.2026 00:49

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Active filter:Manufacturer SRN:CN-MF-000017965

634 device results listed.

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URcheck Liver Function Lyophilized Kit 12

URcheck Liver Function Lyophilized Kit 12

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996097338
Basic UDI-DI: B-06950996097338
Reference: LF-002
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

URcheck Health Check Lyophilized Kit 19

URcheck Health Check Lyophilized Kit 19

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996060400
Basic UDI-DI: B-06950996060400
Reference: SYN-004
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

URcheck Renal Function Lyophilized Kit 9

URcheck Renal Function Lyophilized Kit 9

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996045995
Basic UDI-DI: B-06950996045995
Reference: KF-003
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

URcheck Clinical Emergency Lyophilized Kit 12

URcheck Clinical Emergency Lyophilized Kit 12

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996033657
Basic UDI-DI: B-06950996033657
Reference: EC-002
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

URcheck Cardiovascular Risk Marker Lyophilized Kit 5

URcheck Cardiovascular Risk Marker Lyophilized Kit 5

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996022750
Basic UDI-DI: B-06950996022750
Reference: CAR-002
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

URcheck Electrolytes Lyophilized Kit 9

URcheck Electrolytes Lyophilized Kit 9

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996011686
Basic UDI-DI: B-06950996011686
Reference: ELE-001
EMDN: W01010404
EMDN description: MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

FDDDI-402a-DR10/FDDDI-402a-DR/FDDDI-402a-DR10LH/FDDDI-402a-DRLH/FDDDI-402a-DR10HG/FDDDI-402a-DRHG

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

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996003803
Basic UDI-DI: 69509960FDDDI-402a-DRCP
Reference: FDDDI-402a-DR10
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Safety summary (SSCP/SSP): CEDR-FDDDI-402a-11.1 · Rev. 6.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 10:48

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

10 tests/kit

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

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996003766
Basic UDI-DI: 69509960FEPSA-402a-DRZB
Reference: FEPSA-402a-DR10
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Safety summary (SSCP/SSP): CEDR-FEPSA-402a-11.1-OG · Rev. 2.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 10:48

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

COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)

GCFCRA-T525a-DRH1，GCFCRA-T525a-DRH5，GCFCRA-T525a-DRH7，GCFCRA-T525a-DRH20

IVD Class CIVDR 2017/746On the marketKitReagentSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996002806
Basic UDI-DI: 69509960GCFCRA-T525aDRH6M
Reference: GCFCRA-T525a-DRH1
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: France
Safety summary (SSCP/SSP): CEDR-SSP-OG007 · Rev. 1.3
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 10:48

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

COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)

-

IVD Class CIVDR 2017/746On the marketKitReagentSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996002813
Basic UDI-DI: 69509960GCFCRA-T525aDRH6M
Reference: GCFCRA-T525a-DRH5
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: -
Safety summary (SSCP/SSP): CEDR-SSP-OG007 · Rev. 1.3
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 03:57

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

COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)

-

IVD Class CIVDR 2017/746On the marketKitReagentSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996002820
Basic UDI-DI: 69509960GCFCRA-T525aDRH6M
Reference: GCFCRA-T525a-DRH7
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: -
Safety summary (SSCP/SSP): CEDR-SSP-OG007 · Rev. 1.3
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 03:57

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

COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)

-

IVD Class CIVDR 2017/746On the marketKitReagentSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996002837
Basic UDI-DI: 69509960GCFCRA-T525aDRH6M
Reference: GCFCRA-T525a-DRH20
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: -
Safety summary (SSCP/SSP): CEDR-SSP-OG007 · Rev. 1.3
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 03:57

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

-

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

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996003773
Basic UDI-DI: 69509960FEPSA-402a-DRZB
Reference: FEPSA-402a-DR
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Safety summary (SSCP/SSP): CEDR-FEPSA-402a-11.1-OG · Rev. 2.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 03:57

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

-

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

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996003810
Basic UDI-DI: 69509960FDDDI-402a-DRCP
Reference: FDDDI-402a-DR
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: -
Safety summary (SSCP/SSP): CEDR-FDDDI-402a-11.1 · Rev. 6.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 03:57

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

-

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

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996032568
Basic UDI-DI: 69509960FDDDI-402a-DRCP
Reference: FDDDI-402a-DRLH
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: -
Safety summary (SSCP/SSP): CEDR-FDDDI-402a-11.1 · Rev. 6.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 03:57

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

-

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

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996053716
Basic UDI-DI: 69509960FDDDI-402a-DRCP
Reference: FDDDI-402a-DR10LH
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: -
Safety summary (SSCP/SSP): CEDR-FDDDI-402a-11.1 · Rev. 6.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 03:57

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

-

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

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996061162
Basic UDI-DI: 69509960FEPSA-402a-DRZB
Reference: FEPSA-402a-DR10LH
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Safety summary (SSCP/SSP): CEDR-FEPSA-402a-11.1-OG · Rev. 2.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 03:57

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

-

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

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996064521
Basic UDI-DI: 69509960FEPSA-402a-DRZB
Reference: FEPSA-402a-DRLH
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: -
Safety summary (SSCP/SSP): CEDR-FEPSA-402a-11.1-OG · Rev. 2.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 03:57

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

-

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

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996075381
Basic UDI-DI: 69509960FDDDI-402a-DRCP
Reference: FDDDI-402a-DR10HG
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: -
Safety summary (SSCP/SSP): CEDR-FDDDI-402a-11.1 · Rev. 6.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 03:57

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

-

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

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996093576
Basic UDI-DI: 69509960FDDDI-402a-DRCP
Reference: FDDDI-402a-DRHG
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: -
Safety summary (SSCP/SSP): CEDR-FDDDI-402a-11.1 · Rev. 6.0
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 16.07.2026 03:57

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