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

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669 device results listed.

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FERR Control

FEFER-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FEFER-PN2077
Basic UDI-DI: B-FEFER-PN2077
Reference: FEFER-PN20
EMDN: W0102152006
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Ferritin Quantitative Test Kit (Time-Resolved FIA)

FEFER-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FEFER-402aXC
Basic UDI-DI: B-FEFER-402aXC
Reference: FEFER-402a
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

CEA Control

FECEA-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FECEA-PN20WE
Basic UDI-DI: B-FECEA-PN20WE
Reference: FECEA-PN20
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

CEA Quantitative Test Kit (Time-Resolved FIA)

FECEA-402a

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FECEA-402aNN
Basic UDI-DI: B-FECEA-402aNN
Reference: FECEA-402a
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Calcitonin Quantitative Test Kit (Time-Resolved FIA)

FECAL-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FECAL-402aQZ
Basic UDI-DI: B-FECAL-402aQZ
Reference: FECAL-402a
EMDN: W0102060301
EMDN description: CALCITONIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

AFP Control

FEAFP-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FEAFP-PN203X
Basic UDI-DI: B-FEAFP-PN203X
Reference: FEAFP-PN20
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

AFP Quantitative Test Kit (Time-Resolved FIA)

FEAFP-302a

IVD generalIVDDOn the marketKitProfessional testingReagentSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FEAFP-302aTV
Basic UDI-DI: B-FEAFP-302aTV
Reference: FEAFP-302a
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

CRP Quantitative Test Kit (Time-Resolved FIA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDWCR-402a7R
Basic UDI-DI: B-FDWCR-402a7R
Reference: FDWCR-402a
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:23

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI Control

FDTRO-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDTRO-PN20LG
Basic UDI-DI: B-FDTRO-PN20LG
Reference: FDTRO-PN20
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:23

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnI Quantitative Test Kit (Time-Resolved FIA)

FDTRO-402c

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDTRO-402cCU
Basic UDI-DI: B-FDTRO-402cCU
Reference: FDTRO-402c
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:22

Manufacturer products Authorised representative products Authorised representative actors View details

cTnI Quantitative Test Kit (Time-Resolved FIA)

FDTRO-402b

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDTRO-402bCS
Basic UDI-DI: B-FDTRO-402bCS
Reference: FDTRO-402b
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:22

Manufacturer products Authorised representative products Authorised representative actors View details

cTnT Control

FDTNT-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDTNT-PN20LD
Basic UDI-DI: B-FDTNT-PN20LD
Reference: FDTNT-PN20
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:22

Manufacturer products Authorised representative products Authorised representative actors View details

cTnT Quantitative Test Kit (Time-Resolved FIA)

FDTNT-

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDTNT-402aCM
Basic UDI-DI: B-FDTNT-402aCM
Reference: FDTNT-402a
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:22

Manufacturer products Authorised representative products Authorised representative actors View details

SAA Control

FDSAA-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDSAA-PN2056
Basic UDI-DI: B-FDSAA-PN2056
Reference: FDSAA-PN20
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:22

Manufacturer products Authorised representative products Authorised representative actors View details

SAA QuantitativeTest Kit (Time-Resolved FIA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDSAA-402aVB
Basic UDI-DI: B-FDSAA-402aVB
Reference: FDSAA-402a
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:22

Manufacturer products Authorised representative products Authorised representative actors View details

PCT / IL-6 Quantitative Test Kit (Time-Resolved FIA)

FDPI-T402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDPI-T402a58
Basic UDI-DI: B-FDPI-T402a58
Reference: FDPI-T402a
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:22

Manufacturer products Authorised representative products Authorised representative actors View details

PCT/IL-6 Control

FDPI-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDPI-PN209Z
Basic UDI-DI: B-FDPI-PN209Z
Reference: FDPI-PN20
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:22

Manufacturer products Authorised representative products Authorised representative actors View details

PCT Control

FDPCT-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDPCT-PN20C6
Basic UDI-DI: B-FDPCT-PN20C6
Reference: FDPCT-PN20
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:22

Manufacturer products Authorised representative products Authorised representative actors View details

PCT Quantitative Test Kit (Time-Resolved FIA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDPCT-402a4E
Basic UDI-DI: B-FDPCT-402a4E
Reference: FDPCT-402a
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:22

Manufacturer products Authorised representative products Authorised representative actors View details

PCT/CRP Quantitative Test Kit (Time-Resolved FIA)

FDPC-T402a-G16

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FDPC-T402a-G16AF
Basic UDI-DI: B-FDPC-T402a-G16AF
Reference: FDPC-T402a-G16
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:22

Manufacturer products Authorised representative products Authorised representative actors View details