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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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15.09.2026 21:08

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Active filter:Manufacturer SRN:SE-MF-000007811

19 device results listed.

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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

AMH Control

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Fujirebio Diagnostics AB
Manufacturer SRN: SE-MF-000007811
UDI-DI: 17350066140579
Basic UDI-DI: 7350066140579M
Reference: 660-20
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Sweden
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

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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

Lung Marker Control

240-20

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Fujirebio Diagnostics AB
Manufacturer SRN: SE-MF-000007811
UDI-DI: 17350066140531
Basic UDI-DI: B-17350066140531
Reference: 240-20
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 10:14

Manufacturer products View details

CanAg SCC EIA

800-10

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Fujirebio Diagnostics AB
Manufacturer SRN: SE-MF-000007811
UDI-DI: 17350066140401
Basic UDI-DI: B-17350066140401
Reference: 800-10
EMDN: W0102030116
EMDN description: SQUAMOUS CELL CARCINOMA ANTIGEN
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 10:14

Manufacturer products View details

Mesothelin Control

360-20

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Fujirebio Diagnostics AB
Manufacturer SRN: SE-MF-000007811
UDI-DI: 17350066140524
Basic UDI-DI: B-17350066140524
Reference: 360-20
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 10:14

Manufacturer products View details

CanAg AFP EIA

600-10

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Fujirebio Diagnostics AB
Manufacturer SRN: SE-MF-000007811
UDI-DI: 17350066140371
Basic UDI-DI: B-17350066140371
Reference: 600-10
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 10:14

Manufacturer products View details

CanAg S100 EIA

708-10

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Fujirebio Diagnostics AB
Manufacturer SRN: SE-MF-000007811
UDI-DI: 17350066140388
Basic UDI-DI: B-17350066140388
Reference: 708-10
EMDN: W0102039012
EMDN description: PROTEIN S-100 B
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 10:14

Manufacturer products View details

CanAg NSE EIA

420-10

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Fujirebio Diagnostics AB
Manufacturer SRN: SE-MF-000007811
UDI-DI: 17350066140340
Basic UDI-DI: B-17350066140340
Reference: 420-10
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 10:14

Manufacturer products View details

CanAg CEA EIA

401-10

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Fujirebio Diagnostics AB
Manufacturer SRN: SE-MF-000007811
UDI-DI: 17350066140289
Basic UDI-DI: B-17350066140289
Reference: 401-10
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 10:14

Manufacturer products View details

CanAg CA125 EIA

400-10

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Fujirebio Diagnostics AB
Manufacturer SRN: SE-MF-000007811
UDI-DI: 17350066140241
Basic UDI-DI: B-17350066140241
Reference: 400-10
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 10:14

Manufacturer products View details

CanAg ProGRP EIA

220-10

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Fujirebio Diagnostics AB
Manufacturer SRN: SE-MF-000007811
UDI-DI: 17350066140159
Basic UDI-DI: B-17350066140159
Reference: 220-10
EMDN: W0102030121
EMDN description: PRO-GASTRIN-RELEASING PEPTIDE
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 10:14

Manufacturer products View details

CanAg CA15-3 EIA

200-10

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Fujirebio Diagnostics AB
Manufacturer SRN: SE-MF-000007811
UDI-DI: 17350066140081
Basic UDI-DI: B-17350066140081
Reference: 200-10
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 10:14

Manufacturer products View details

CanAg CA19-9 EIA

120-10

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Fujirebio Diagnostics AB
Manufacturer SRN: SE-MF-000007811
UDI-DI: 17350066140050
Basic UDI-DI: B-17350066140050
Reference: 120-10
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 10:14

Manufacturer products View details

CanChek Tumor Marker Control

107-20

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Fujirebio Diagnostics AB
Manufacturer SRN: SE-MF-000007811
UDI-DI: 17350066140036
Basic UDI-DI: B-17350066140036
Reference: 107-20
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 10:14

Manufacturer products View details

CanAg CA242 EIA

101-10

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Fujirebio Diagnostics AB
Manufacturer SRN: SE-MF-000007811
UDI-DI: 17350066140012
Basic UDI-DI: B-17350066140012
Reference: 101-10
EMDN: W0102030108
EMDN description: CANCER ANTIGEN 242
First on market country: Sweden
Authorised representative: -
Last updated: 11.07.2026 10:14

Manufacturer products View details