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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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Terminal Deoxynucleotidyl Transferase (TdT {P})

CP134CK

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627007902
Basic UDI-DI: B-00847627007902
Reference: CP134CK
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 29.07.2026 23:15

Manufacturer products Authorised representative products Authorised representative actors View details

Terminal Deoxynucleotidyl Transferase (TdT {P})

CP134AK

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627007896
Basic UDI-DI: B-00847627007896
Reference: CP134AK
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 29.07.2026 23:15

Manufacturer products Authorised representative products Authorised representative actors View details

CM406C

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627007421
Basic UDI-DI: B-00847627007421
Reference: CM406C
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 29.07.2026 23:15

Manufacturer products Authorised representative products Authorised representative actors View details

CM406A

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627007414
Basic UDI-DI: B-00847627007414
Reference: CM406A
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 29.07.2026 23:15

Manufacturer products Authorised representative products Authorised representative actors View details

CM130C

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627006363
Basic UDI-DI: B-00847627006363
Reference: CM130C
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 29.07.2026 23:15

Manufacturer products Authorised representative products Authorised representative actors View details

CM130B

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627006356
Basic UDI-DI: B-00847627006356
Reference: CM130B
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 29.07.2026 23:15

Manufacturer products Authorised representative products Authorised representative actors View details

CM130A

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627006349
Basic UDI-DI: B-00847627006349
Reference: CM130A
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 29.07.2026 23:15

Manufacturer products Authorised representative products Authorised representative actors View details

CM022A

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627005588
Basic UDI-DI: B-00847627005588
Reference: CM022
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 29.07.2026 23:15

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® AFP

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771200479
Basic UDI-DI: B-08056771200479
Reference: 314471
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Italy
Authorised representative: -
Last updated: 28.07.2026 03:40

Manufacturer products 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

Total Prostate Specific Antigen (tPSA) Diagnostic Kit (Immunochromatographic Assay)

Total Prostate Specific Antigen (tPSA) Diagnostic Kit (Immunochromatographic Assay)

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762773
Basic UDI-DI: 697134876046C277335
Reference: MF-046-20
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

Free Prostate Specific Antigen (fPSA) Diagnostic Kit (Immunochromatographic Assay)

Free Prostate Specific Antigen (fPSA) Diagnostic Kit (Immunochromatographic Assay)

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762698
Basic UDI-DI: 697134876047C26983V
Reference: MF-047-20
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

Total Prostate Specific Antigen (tPSA) Diagnostic Kit (Immunochromatographic Assay)

-

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348764715
Basic UDI-DI: 697134876046C277335
Reference: MF-046-25
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

Free Prostate Specific Antigen (fPSA) Diagnostic Kit (Immunochromatographic Assay)

-

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348764722
Basic UDI-DI: 697134876047C26983V
Reference: MF-047-25
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors 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

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

Fecal Occult Blood (FOB) Quantitative Detection 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: 06971348765606
Basic UDI-DI: B-06971348765606
Reference: MF-126-25
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.07.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

Fecal Occult Blood (FOB) Diagnostic Kit

25 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348765576
Basic UDI-DI: B-06971348765576
Reference: MF-74-25
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.07.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

Fecal Occult Blood (FOB) Quantitative Detection 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: 06971348763237
Basic UDI-DI: B-06971348763237
Reference: MF-126-20
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.07.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details