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PIVKA-II Detection Kit (Chemiluminescence Immunoassay)

2×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202224317
Basic UDI-DI: B-06942202224317
Reference: 3014256
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:51

Manufacturer products Authorised representative products Authorised representative actors View details

Cancer Antigen 50 Detection Kit (Chemiluminescence Immunoassay)

2×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202224300
Basic UDI-DI: B-06942202224300
Reference: 3014822
EMDN: W0102030104
EMDN description: CANCER ANTIGEN 50
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:51

Manufacturer products Authorised representative products Authorised representative actors View details

Cancer Antigen 242 Detection Kit (Chemiluminescence Immunoassay)

2×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202224294
Basic UDI-DI: B-06942202224294
Reference: 3014820
EMDN: W0102030108
EMDN description: CANCER ANTIGEN 242
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:51

Manufacturer products Authorised representative products Authorised representative actors View details

Cytokeratin 19 Fragments Detection Kit (Chemiluminescence Immunoassay)

2×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202224287
Basic UDI-DI: B-06942202224287
Reference: 3013796
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:51

Manufacturer products Authorised representative products Authorised representative actors View details

Cancer Antigen 72-4 Detection Kit (Chemiluminescence Immunoassay)

2×50 tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202224263
Basic UDI-DI: B-06942202224263
Reference: 3013898
EMDN: W0102030105
EMDN description: CANCER ANTIGEN 72-4
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:51

Manufacturer products Authorised representative products Authorised representative actors View details

Cancer Antigen 125 Detection Kit (Chemiluminescence Immunoassay)

2×50 tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202224225
Basic UDI-DI: B-06942202224225
Reference: 3013894
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:51

Manufacturer products Authorised representative products Authorised representative actors View details

Cancer Antigen 15-3 Detection Kit (Chemiluminescence Immunoassay)

2×50 tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202224218
Basic UDI-DI: B-06942202224218
Reference: 3013793
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 16:51

Manufacturer products Authorised representative products Authorised representative actors View details

PSA Qualitative Rapid Test Cassette

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983120074
Basic UDI-DI: B-06936983120074
Reference: TPS-Q402
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:29

Manufacturer products Authorised representative products Authorised representative actors View details

PSA Qualitative Rapid Test Cassette

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983100960
Basic UDI-DI: B-06936983100960
Reference: TPS-Q402
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:28

Manufacturer products Authorised representative products Authorised representative actors View details

06936791010017

96 tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Zhongshan Bio-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000028828
UDI-DI: 06936791010017
Basic UDI-DI: B-06936791010017
Reference: AP0101-96
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 14:14

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Pro-Gastrin-Releasing-Peptide (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858311
Basic UDI-DI: B-06933289858311
Reference: W497P0009
EMDN: W0102030121
EMDN description: PRO-GASTRIN-RELEASING PEPTIDE
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.08.2026 13:06

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Pro-Gastrin-Releasing-Peptide (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858304
Basic UDI-DI: B-06933289858304
Reference: W497P0008
EMDN: W0102030121
EMDN description: PRO-GASTRIN-RELEASING PEPTIDE
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.08.2026 13:06

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Pro-Gastrin-Releasing-Peptide (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858298
Basic UDI-DI: B-06933289858298
Reference: W497P0007
EMDN: W0102030121
EMDN description: PRO-GASTRIN-RELEASING PEPTIDE
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.08.2026 13:06

Manufacturer products Authorised representative products Authorised representative actors View details

SmarLumi

Pro-Gastrin-Releasing-Peptide (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289858281
Basic UDI-DI: B-06933289858281
Reference: W497P0006
EMDN: W0102030121
EMDN description: PRO-GASTRIN-RELEASING PEPTIDE
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 03.08.2026 13:06

Manufacturer products Authorised representative products Authorised representative actors View details

PIVKA-II Detection Kit (Chemiluminescence Immunoassay)

1×100 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794571434
Basic UDI-DI: B-06925794571434
Reference: 3010686
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:38

Manufacturer products Authorised representative products Authorised representative actors View details

PIVKA-II Detection Kit (Chemiluminescence Immunoassay)

1×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794571427
Basic UDI-DI: B-06925794571427
Reference: 3010666
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:38

Manufacturer products Authorised representative products Authorised representative actors View details

Squamous Cell Carcinoma Antigen Detection Kit (Chemiluminescence Immunoassay)

1×100 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794523747
Basic UDI-DI: B-06925794523747
Reference: 3013433
EMDN: W0102030116
EMDN description: SQUAMOUS CELL CARCINOMA ANTIGEN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:37

Manufacturer products Authorised representative products Authorised representative actors View details

Squamous Cell Carcinoma Antigen Detection Kit (Chemiluminescence Immunoassay)

1×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794523723
Basic UDI-DI: B-06925794523723
Reference: 3013442
EMDN: W0102030116
EMDN description: SQUAMOUS CELL CARCINOMA ANTIGEN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:37

Manufacturer products Authorised representative products Authorised representative actors View details

Human Epididymal Protein 4 Detection Kit (Chemiluminescence Immunoassay)

1×100 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794523419
Basic UDI-DI: B-06925794523419
Reference: 3013429
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:37

Manufacturer products Authorised representative products Authorised representative actors View details

Human Epididymal Protein 4 Detection Kit (Chemiluminescence Immunoassay)

1×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794523396
Basic UDI-DI: B-06925794523396
Reference: 3013420
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:37

Manufacturer products Authorised representative products Authorised representative actors View details