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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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CA125 Assay Kit (ECLIA)

CA125 Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SEK007DL
Basic UDI-DI: B-SEK007DL
Reference: SE-K007
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

CYFRA21-1 Assay Kit (ECLIA)

CYFRA21-1 Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SEK006DJ
Basic UDI-DI: B-SEK006DJ
Reference: SE-K006
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

CA72-4 Assay Kit (ECLIA)

CA72-4 Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SEK004DE
Basic UDI-DI: B-SEK004DE
Reference: SE-K004
EMDN: W0102030105
EMDN description: CANCER ANTIGEN 72-4
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

CA19-9 Assay Kit (ECLIA)

CA19-9 Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SEK003DC
Basic UDI-DI: B-SEK003DC
Reference: SE-K003
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

CA15-3 Assay Kit (ECLIA)

CA15-3 Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SEK002DA
Basic UDI-DI: B-SEK002DA
Reference: SE-K002
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

AFP Assay Kit (ECLIA)

AFP Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SEK001D8
Basic UDI-DI: B-SEK001D8
Reference: SE-K001
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

CEA Assay Kit (ECLIA)

CEA Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SE-K005QU
Basic UDI-DI: B-SE-K005QU
Reference: SE-K005
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

SCC Squamous Cell Carcinoma Antigen (CLIA)

SCC Squamous Cell Carcinoma Antigen (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-SCC706-AEVY
Basic UDI-DI: B-SCC706-AEVY
Reference: SCC706-AE
EMDN: W0102030116
EMDN description: SQUAMOUS CELL CARCINOMA ANTIGEN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 05:39

Manufacturer products Authorised representative products Authorised representative actors View details

50 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022030E7
Basic UDI-DI: B-SAC2022030E7
Reference: SAC2022030
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products View details

25 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022029EN
Basic UDI-DI: B-SAC2022029EN
Reference: SAC2022029
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products View details

10 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022028EL
Basic UDI-DI: B-SAC2022028EL
Reference: SAC2022028
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products View details

50 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022024EC
Basic UDI-DI: B-SAC2022024EC
Reference: SAC2022024
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products View details

25 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022023EA
Basic UDI-DI: B-SAC2022023EA
Reference: SAC2022023
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products View details

10 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022022E8
Basic UDI-DI: B-SAC2022022E8
Reference: SAC2022022
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:35

Manufacturer products View details

5 tests/kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022007EC
Basic UDI-DI: B-SAC2022007EC
Reference: SAC2022007
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:34

Manufacturer products View details

5 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-SAC2022005E8
Basic UDI-DI: B-SAC2022005E8
Reference: SAC2022005
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Denmark
Authorised representative: -
Last updated: 15.07.2026 05:34

Manufacturer products View details

50 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R197153Z
Basic UDI-DI: B-R197153Z
Reference: R19715
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 05:24

Manufacturer products Authorised representative products Authorised representative actors View details

30 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R197143X
Basic UDI-DI: B-R197143X
Reference: R19714
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 05:24

Manufacturer products Authorised representative products Authorised representative actors View details

200 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R197133V
Basic UDI-DI: B-R197133V
Reference: R19713
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 05:24

Manufacturer products Authorised representative products Authorised representative actors View details

100 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Rayto Life and Analytical Sciences Co., Ltd.
Manufacturer SRN: CN-MF-000011141
UDI-DI: D-R197123T
Basic UDI-DI: B-R197123T
Reference: R19712
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 15.07.2026 05:24

Manufacturer products Authorised representative products Authorised representative actors View details