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01.08.2026 00:16

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CanAg Glypican-3 EIA

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Fujirebio Diagnostics AB
Manufacturer SRN: SE-MF-000007811
UDI-DI: 17350066140593
Basic UDI-DI: 7350066140599R
Reference: 503-10
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 31.07.2026 22:24

Manufacturer products View details

HE4 EIA

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Fujirebio Diagnostics AB
Manufacturer SRN: SE-MF-000007811
UDI-DI: 17350066140302
Basic UDI-DI: 7350066140308Z
Reference: 404-10
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
First on market country: Sweden
Authorised representative: -
Last updated: 31.07.2026 22:24

Manufacturer products View details

CanAg Free PSA EIA

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Fujirebio Diagnostics AB
Manufacturer SRN: SE-MF-000007811
UDI-DI: 17350066140203
Basic UDI-DI: 7350066140208W
Reference: 350-10
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
First on market country: Sweden
Authorised representative: -
Last updated: 31.07.2026 22:15

Manufacturer products View details

CanAg PSA EIA

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Fujirebio Diagnostics AB
Manufacturer SRN: SE-MF-000007811
UDI-DI: 17350066140173
Basic UDI-DI: 73500661401799
Reference: 340-10
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Sweden
Authorised representative: -
Last updated: 31.07.2026 22:15

Manufacturer products View details

CYFRA 21-1 EIA

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Fujirebio Diagnostics AB
Manufacturer SRN: SE-MF-000007811
UDI-DI: 17350066140135
Basic UDI-DI: 7350066140138Z
Reference: 211-10
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Sweden
Authorised representative: -
Last updated: 31.07.2026 22:15

Manufacturer products View details

pro-Gastrin-Releasing Peptide (eCLIA)

50T, 2x50T, 100T, 2x100T

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341686017
Basic UDI-DI: 69703416803205051JC
Reference: 0320501301
EMDN: W0102030121
EMDN description: PRO-GASTRIN-RELEASING PEPTIDE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 21:19

Manufacturer products Authorised representative products Authorised representative actors View details

CA50 (eCLIA)

50T, 2×50T, 100T, 2×100T

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984064352
Basic UDI-DI: 69703416803205087JZ
Reference: 0320509401
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 21:14

Manufacturer products Authorised representative products Authorised representative actors View details

Cancer Antigen 72-4 (eCLIA)

: 50T, 2×50T, 100T, 2×100T

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984062587
Basic UDI-DI: 69703416803205052JE
Reference: 0320501701
EMDN: W0102030105
EMDN description: CANCER ANTIGEN 72-4
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 21:14

Manufacturer products Authorised representative products Authorised representative actors View details

Neuronen-Spezifische Enolase (eCLIA)

50T, 2x50T, 100T, 2x100T

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984062563
Basic UDI-DI: 69703416803205025JB
Reference: 0320501601
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 21:13

Manufacturer products Authorised representative products Authorised representative actors View details

Squamous Cell Carcinoma (eCLIA)

50T, 2x50T, 100T, 2x50T

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341689223
Basic UDI-DI: 69703416803205050JA
Reference: 0320501201
EMDN: W0102030116
EMDN description: SQUAMOUS CELL CARCINOMA ANTIGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 21:13

Manufacturer products Authorised representative products Authorised representative actors View details

Carcinoembryonic Antigen (eCLIA)

50T, 2x50T, 100T, 2x100T

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341685843
Basic UDI-DI: 69703416803205062JH
Reference: 0320500501
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 21:13

Manufacturer products Authorised representative products Authorised representative actors View details

Cancer Antigen 125 (eCLIA)

50T, 100T, 2×50T, 2×100T

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341685829
Basic UDI-DI: 69703416803205049JR
Reference: 0320500901
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 21:13

Manufacturer products Authorised representative products Authorised representative actors View details

Carbonhydrate Antigen 19-9 (eCLIA)

IVD Class CNot specifiedOn the market

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341685805
Basic UDI-DI: 69703416803205024J9
Reference: 06970341685805
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 21:13

Manufacturer products Authorised representative products Authorised representative actors View details

Cancer Antigen 15-3 (eCLIA)

50T, 2×50T, 100T, 2×100T

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341685782
Basic UDI-DI: 69703416803205027JF
Reference: 0320500701
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 21:13

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha-Fetoprotein (eCLIA)

50T, 2x50T, 100T, 2x100T

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341685713
Basic UDI-DI: 69703416803205048JP
Reference: 0320501401
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 21:13

Manufacturer products Authorised representative products Authorised representative actors View details

Squamous Cell Carcinoma Antigen test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700408928
Basic UDI-DI: 697029753457M3
Reference: HGCL73
EMDN: W0102030116
EMDN description: SQUAMOUS CELL CARCINOMA ANTIGEN
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

α-fetoprotein test (Up-converting Phosphor Technology)

Please see the IFU

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700405644
Basic UDI-DI: 697029753439LZ
Reference: HGUPT17
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Total Prostate Specific Antigen test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700404876
Basic UDI-DI: 697029753068LL
Reference: HGCL24
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Human Epididymis Protein 4 test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700404852
Basic UDI-DI: 697029753279M3
Reference: HGCL32
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

Carcinoembryonic Antigen test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700404845
Basic UDI-DI: 697029753066LG
Reference: HGCL23
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details