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CA-125 AccuBind ELISA Kit - 96 wells

3025-300

IVD Class CIVDR 2017/746No longer on the marketKitProfessional testing

Manufacturer: Monobind Inc.
Manufacturer SRN: US-MF-000021611
UDI-DI: 00816870020471
Basic UDI-DI: 081687002CA1253025PQ
Reference: 3025-300A
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Netherlands
Authorised representative: CEpartner4U
Last updated: 30.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

D-FI-CEA-402GH

CEA Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-CEA-402GH
Basic UDI-DI: B-FI-CEA-402GH
Reference: FI-CEA-402
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 30.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details

CellSearch Circulating Tumor Cell (CTC) Control Kit

7900003

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingSingle use

Manufacturer: Menarini Silicon Biosystems, Inc
Manufacturer SRN: US-MF-000042008
UDI-DI: 10888385000023
Basic UDI-DI: B-10888385000023
Reference: 7900003
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Germany
Authorised representative: Menarini Silicon Biosystems S.p.A.
Last updated: 30.07.2026 02:26

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Cytokeratin Fragment 21-1 (CYFRA)

IVDR_67_TTN_DUB-C_C_REAG_CYFRA

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414291345
Basic UDI-DI: 0405686902359VZ
Reference: 11354591
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 29.07.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

LIAISON® fPSA

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771200462
Basic UDI-DI: 805677131439156
Reference: 314391
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
First on market country: Italy
Authorised representative: -
Last updated: 28.07.2026 03:40

Manufacturer products View details

CellSearch Circulating Tumor Cell (CTC) Kit

7900001

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Menarini Silicon Biosystems, Inc
Manufacturer SRN: US-MF-000042008
UDI-DI: 10888385000016
Basic UDI-DI: B-10888385000016
Reference: 7900001
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Germany
Authorised representative: Menarini Silicon Biosystems S.p.A.
Last updated: 25.07.2026 01:41

Manufacturer products Authorised representative products Authorised representative actors View details

D-Z003384P

N/A

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Manufacturer SRN: AT-MF-000000254
UDI-DI: D-Z003384P
Basic UDI-DI: B-Z003384P
Reference: Z00338
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Austria
Authorised representative: -
Last updated: 24.07.2026 22:51

Manufacturer products View details

Human Epididymis Protein 4 (HE 4) Diagnostic Kit(Immunochromatographic Assay)

25 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348765521
Basic UDI-DI: B-06971348765521
Reference: MF-09-25
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:53

Manufacturer products Authorised representative products Authorised representative actors View details

Cytokeratin 19 Fragment (Cyfra21-1) Diagnostic Kit(Immunochromatographic Assay)

25 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348765507
Basic UDI-DI: B-06971348765507
Reference: MF-07-25
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:53

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate Antigen 15-3 (CA15-3) Diagnostic Kit(Immunochromatographic Assay)

25 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762315
Basic UDI-DI: B-06971348762315
Reference: MF-06-25
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:53

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate Antigen 125 (CA125) Diagnostic Kit(Immunochromatographic Assay)

25 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762292
Basic UDI-DI: B-06971348762292
Reference: MF-05-25
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:53

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate Antigen 19-9 (CA19-9) Diagnostic Kit(Immunochromatographic Assay)

25 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762261
Basic UDI-DI: B-06971348762261
Reference: MF-04-25
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:53

Manufacturer products Authorised representative products Authorised representative actors View details

α-fetoprotein (AFP) Diagnostic Kit (Immunochromatographic Assay)

25 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762247
Basic UDI-DI: B-06971348762247
Reference: MF-03-25
EMDN: W0102030118
EMDN description: CANCER ASSOCIATED SERUM ANTIGEN
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:53

Manufacturer products Authorised representative products Authorised representative actors View details

Human Epididymis Protein 4 (HE 4) Diagnostic Kit(Immunochromatographic Assay)

20 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348760229
Basic UDI-DI: B-06971348760229
Reference: MF-09-20
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:52

Manufacturer products Authorised representative products Authorised representative actors View details

Cytokeratin 19 Fragment (Cyfra21-1) Diagnostic Kit(Immunochromatographic Assay)

20 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348760120
Basic UDI-DI: B-06971348760120
Reference: MF-07-20
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:52

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate Antigen 19-9 (CA19-9) Diagnostic Kit(Immunochromatographic Assay)

20 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348760090
Basic UDI-DI: B-06971348760090
Reference: MF-04-20
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:52

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate Antigen 15-3 (CA15-3) Diagnostic Kit(Immunochromatographic Assay)

20 Tests/Box

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348760083
Basic UDI-DI: B-06971348760083
Reference: MF-06-20
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:52

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate Antigen 125 (CA125) Diagnostic Kit(Immunochromatographic Assay)

20 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348760076
Basic UDI-DI: B-06971348760076
Reference: MF-05-20
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:52

Manufacturer products Authorised representative products Authorised representative actors View details

α-fetoprotein (AFP) Diagnostic Kit (Immunochromatographic Assay)

20 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348760069
Basic UDI-DI: B-06971348760069
Reference: MF-03-20
EMDN: W0102030118
EMDN description: CANCER ASSOCIATED SERUM ANTIGEN
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:52

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)

IVDR_67_TTN_DUB-C_C_REAG_CYFRA

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414291338
Basic UDI-DI: 0405686902359VZ
Reference: 11354590
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details