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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)

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)

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

D-35072

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

D-3467B

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)

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

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D-3306U

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

D-32879

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

D-3066X

Carbohydrate Antigen 19-9 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-3066X
Basic UDI-DI: B-3066X
Reference: /
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 18:16

Manufacturer products Authorised representative products Authorised representative actors View details

D-3036R

Carcinoembryonic Antigen 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-3036R
Basic UDI-DI: B-3036R
Reference: /
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 18:08

Manufacturer products Authorised representative products Authorised representative actors View details

D-3026P

Cancer Antigen 125 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-3026P
Basic UDI-DI: B-3026P
Reference: /
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 18:07

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate Antigen 125 Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 20850076346342
Basic UDI-DI: B-20850076346342
Reference: CECA125-301a
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 15:03

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate Antigen 19-9 Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 20850076346335
Basic UDI-DI: B-20850076346335
Reference: CECA199-301a
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 15:03

Manufacturer products Authorised representative products Authorised representative actors View details

Carcinoembryonic Antigen Test Kit (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 20850076346328
Basic UDI-DI: B-20850076346328
Reference: CECEA-301a
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 15:03

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-CEA

IVD Class CNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912718604
Basic UDI-DI: 692591270023GV
Reference: C86004
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:48

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-CA 19-9

IVD Class CNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912718611
Basic UDI-DI: 692591270026H3
Reference: C86007
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:48

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-CA 125

IVD Class CNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912718628
Basic UDI-DI: 692591270024GX
Reference: C86005
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:48

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-CYFRA 21-1

IVD Class CNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912718765
Basic UDI-DI: 692591270027H5
Reference: C86028
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:48

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Total PSA

IVD Class CNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912719250
Basic UDI-DI: 692591270097HS
Reference: C86000
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:48

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Free PSA

IVD Class CNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912719267
Basic UDI-DI: 692591270098HU
Reference: C86001
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:48

Manufacturer products Authorised representative products Authorised representative actors View details