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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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Squamous Cell Carcinoma assay (CLIA)

Squamous Cell Carcinoma assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7C21DJ
Basic UDI-DI: B-7C21DJ
Reference: 7C21V1-B-EU, 7C21U1-B-EU, 7C21P1-B-EU
EMDN: W0102030116
EMDN description: SQUAMOUS CELL CARCINOMA ANTIGEN
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:27

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate Antigen 242 assay (CLIA)

Carbohydrate Antigen 242 assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7C20DG
Basic UDI-DI: B-7C20DG
Reference: 7C20V1-B-EU, 7C20U1-B-EU, 7C20P1-B-EU
EMDN: W0102030108
EMDN description: CANCER ANTIGEN 242
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:27

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate Antigen 72-4 assay (CLIA)

Carbohydrate Antigen 72-4 assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7C15DP
Basic UDI-DI: B-7C15DP
Reference: 7C15V1-B-EU, 7C15U1-B-EU, 7C15P1-B-EU
EMDN: W0102030105
EMDN description: CANCER ANTIGEN 72-4
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:27

Manufacturer products Authorised representative products Authorised representative actors View details

Cytokeratin 19 Fragment 21-1 assay (CLIA)

Cytokeratin 19 Fragment 21-1 assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7C13DK
Basic UDI-DI: B-7C13DK
Reference: 7C13V1-B-EU, 7C13U1-B-EU, 7C13P1-B-EU
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:27

Manufacturer products Authorised representative products Authorised representative actors View details

Cancer Antigen 15-3 assay (CLIA)

Cancer Antigen 15-3 assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7C10DD
Basic UDI-DI: B-7C10DD
Reference: 7C10V1-B-EU, 7C10U1-B-EU, 7C10P1-B-EU
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:27

Manufacturer products Authorised representative products Authorised representative actors View details

Neuron-Specific Enolase assay (CLIA)

Neuron-Specific Enolase assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7C09DU
Basic UDI-DI: B-7C09DU
Reference: 7C09V1-B-EU, 7C09U1-B-EU, 7C09P1-B-EU
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:27

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate Antigen 19-9 assay (CLIA)

Carbohydrate Antigen 19-9 assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7C04DJ
Basic UDI-DI: B-7C04DJ
Reference: 7C04V1-B-EU, 7C04U1-B-EU, 7C04P1-B-EU
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:27

Manufacturer products Authorised representative products Authorised representative actors View details

Cancer Antigen 125 assay (CLIA)

Cancer Antigen 125 assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7C03DG
Basic UDI-DI: B-7C03DG
Reference: 7C03V1-B-EU, 7C03U1-B-EU, 7C03P1-B-EU
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:27

Manufacturer products Authorised representative products Authorised representative actors View details

Cancer Embryo Antigen assay (CLIA)

Cancer Embryo Antigen assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7C02DE
Basic UDI-DI: B-7C02DE
Reference: 7C02V1-B-EU, 7C02U1-B-EU, 7C02P1-B-EU
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:27

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha-Fetoprotein assay (CLIA)

Alpha-Fetoprotein assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7C01DC
Basic UDI-DI: B-7C01DC
Reference: 7C01V1-B-EU, 7C01U1-B-EU, 7C01P1-B-EU
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:27

Manufacturer products Authorised representative products Authorised representative actors View details

Beta-2 Microglobulin (β2-MG) Assay Kit (Latex-enhanced Immunoturbidimetric Method)

Beta-2 Microglobulin (β2-MG) Assay Kit (Latex-enhanced Immunoturbidimetric Method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: YHLO BIOTECH (NANJING) CO., LTD.
Manufacturer SRN: CN-MF-000050474
UDI-DI: D-76H50TXL
Basic UDI-DI: B-76H50TXL
Reference: 76H50T
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 09:19

Manufacturer products Authorised representative products Authorised representative actors View details

Beta-2 Microglobulin (β2-MG) Assay Kit (Latex-enhanced Immunoturbidimetric Method)

Beta-2 Microglobulin (β2-MG) Assay Kit (Latex-enhanced Immunoturbidimetric Method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: YHLO BIOTECH (NANJING) CO., LTD.
Manufacturer SRN: CN-MF-000050474
UDI-DI: D-76H50TSCVL
Basic UDI-DI: B-76H50TSCVL
Reference: 76H50TSC
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 09:19

Manufacturer products Authorised representative products Authorised representative actors View details

Beta-2 Microglobulin (β2-MG) Assay Kit (Latex-enhanced Immunoturbidimetric Method)

Beta-2 Microglobulin (β2-MG) Assay Kit (Latex-enhanced Immunoturbidimetric Method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: YHLO BIOTECH (NANJING) CO., LTD.
Manufacturer SRN: CN-MF-000050474
UDI-DI: D-76H150TAX
Basic UDI-DI: B-76H150TAX
Reference: 76H150T
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 09:19

Manufacturer products Authorised representative products Authorised representative actors View details

Beta-2 Microglobulin (β2-MG) Assay Kit (Latex-enhanced Immunoturbidimetric Method)

Beta-2 Microglobulin (β2-MG) Assay Kit (Latex-enhanced Immunoturbidimetric Method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: YHLO BIOTECH (NANJING) CO., LTD.
Manufacturer SRN: CN-MF-000050474
UDI-DI: D-76H150TSCBK
Basic UDI-DI: B-76H150TSCBK
Reference: 76H150TSC
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 09:19

Manufacturer products Authorised representative products Authorised representative actors View details

Neuron-specific Enolase Quantitative Detection KIT (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-3697P
Basic UDI-DI: B-3697P
Reference: /
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

Squamous-cell Carcinoma Quantitative Detection KIT (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-35072
Basic UDI-DI: B-35072
Reference: /
EMDN: W0102030116
EMDN description: SQUAMOUS CELL CARCINOMA ANTIGEN
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 18:36

Manufacturer products Authorised representative products Authorised representative actors View details

Human Epididymis Protein 4 Quantitative Detection KIT (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-3467B
Basic UDI-DI: B-3467B
Reference: /
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

Access CEA (Reagent Pack)

Access CEA (Reagent Pack)

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-33200FE
Basic UDI-DI: B-33200FE
Reference: 33200
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

Cyfra21-1 Quantitative Detection KIT (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-3306U
Basic UDI-DI: B-3306U
Reference: /
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

Cancer Antigen 15-3 Quantitative Detection KIT (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-32879
Basic UDI-DI: B-32879
Reference: /
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details