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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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372 device results listed.

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08435287144475

ANTI-NUCLEAR ANTIBODIES HEp-2 (ANA-HEp-2)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287144475
Basic UDI-DI: B-08435287144475
Reference: 44547
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:48

Manufacturer products View details

08435287144093

ANTI-NUCLEAR ANTIBODIES HEp-2 (ANA-HEp-2)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287144093
Basic UDI-DI: B-08435287144093
Reference: 44509
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:48

Manufacturer products View details

08435287144086

ANTI-NUCLEAR ANTIBODIES HEp-2 (ANA-HEp-2)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287144086
Basic UDI-DI: B-08435287144086
Reference: 44508
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:48

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08435287144031

ANA-Sp POSITIVE CONTROL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287144031
Basic UDI-DI: B-08435287144031
Reference: 44503
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:48

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08435287144024

ANA-Ho POSITIVE CONTROL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287144024
Basic UDI-DI: B-08435287144024
Reference: 44502
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:48

Manufacturer products View details

08435287141481

ANTI-ENDOMYSIUM ANTIBODIES (AEA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287141481
Basic UDI-DI: B-08435287141481
Reference: 44148
EMDN: W0102100603
EMDN description: ANTIBODIES TO ENDOMYSIAL AUTOANTIGENES
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:48

Manufacturer products View details

08435287141085

ANTI-NUCLEAR ANTIBODIES HEp-2 (ANA-HEp-2)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287141085
Basic UDI-DI: B-08435287141085
Reference: 44108
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:48

Manufacturer products View details

08435287139273

C-REACTIVE PROTEIN-hs (CRP-hs)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287139273
Basic UDI-DI: B-08435287139273
Reference: 13927
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:48

Manufacturer products View details

08435287139235

ANTI-STREPTOLYSIN O (ASO)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287139235
Basic UDI-DI: B-08435287139235
Reference: 13923
EMDN: W01021104
EMDN description: ANTI-STREPTOLYSIN O (QUANTITATIVE)
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:48

Manufacturer products View details

08435287139211

C-REACTIVE PROTEIN (CRP)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287139211
Basic UDI-DI: B-08435287139211
Reference: 13921
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:48

Manufacturer products View details

08435287135039

SEROLOGY NEGATIVE CONTROL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287135039
Basic UDI-DI: B-08435287135039
Reference: 33503
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:48

Manufacturer products View details

08435287130911

TRANSFERRIN

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287130911
Basic UDI-DI: B-08435287130911
Reference: 13091
EMDN: W0102010307
EMDN description: TRANSFERRIN
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:48

Manufacturer products View details

08435287130850

COMPLEMENT COMPONENT C4

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287130850
Basic UDI-DI: B-08435287130850
Reference: 13085
EMDN: W0102010205
EMDN description: COMPLEMENT COMPONENT C4
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:48

Manufacturer products View details

08435287130843

COMPLEMENT COMPONENT C3

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287130843
Basic UDI-DI: B-08435287130843
Reference: 13084
EMDN: W0102010203
EMDN description: COMPLEMENT COMPONENT C3/C3C
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:48

Manufacturer products View details

08435287130836

IMMUNOGLOBULIN M (IgM)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287130836
Basic UDI-DI: B-08435287130836
Reference: 13083
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:48

Manufacturer products View details

08435287130829

IMMUNOGLOBULIN A (IgA)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287130829
Basic UDI-DI: B-08435287130829
Reference: 13082
EMDN: W0102010101
EMDN description: IMMUNOGLOBULIN A
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:48

Manufacturer products View details

08435287130812

IMMUNOGLOBULIN G (IgG)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287130812
Basic UDI-DI: B-08435287130812
Reference: 13081
EMDN: W0102010105
EMDN description: IMMUNOGLOBULIN G
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:48

Manufacturer products View details

08435287130782

IMMUNOGLOBULIN M (IgM)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287130782
Basic UDI-DI: B-08435287130782
Reference: 31078
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:47

Manufacturer products View details

08435287130775

IMMUNOGLOBULIN A (IgA)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287130775
Basic UDI-DI: B-08435287130775
Reference: 31077
EMDN: W0102010101
EMDN description: IMMUNOGLOBULIN A
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:47

Manufacturer products View details

08435287129274

C-REACTIVE PROTEIN-hs (CRP-hs)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287129274
Basic UDI-DI: B-08435287129274
Reference: 22927
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:47

Manufacturer products View details