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

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22.07.2026 17:10

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372 device results listed.

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08435287180527

ADENOSINE DEAMINASE (ADA) STANDARD

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287180527
Basic UDI-DI: B-08435287180527
Reference: 18052
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:51

Manufacturer products View details

08435287180480

ADA CONTROLS

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287180480
Basic UDI-DI: B-08435287180480
Reference: 18048
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:51

Manufacturer products View details

08435287180374

CONTROL URINE

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287180374
Basic UDI-DI: B-08435287180374
Reference: 18037
EMDN: W0101050207
EMDN description: URINE CONTROLS
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:51

Manufacturer products View details

08435287180367

CONTROL URINE

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287180367
Basic UDI-DI: B-08435287180367
Reference: 18036
EMDN: W0101050207
EMDN description: URINE CONTROLS
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:51

Manufacturer products View details

08435287180022

HEMOGLOBIN A1C CONTROL (ELEVATED)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287180022
Basic UDI-DI: B-08435287180022
Reference: 18002
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:51

Manufacturer products View details

08435287180015

HEMOGLOBIN A1C CONTROL (NORMAL)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287180015
Basic UDI-DI: B-08435287180015
Reference: 18001
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:51

Manufacturer products View details

08435287160024

RPR-CARBON

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287160024
Basic UDI-DI: B-08435287160024
Reference: 36002
EMDN: W0105010301
EMDN description: SYPHILIS ANTIGEN DETECTION
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:51

Manufacturer products View details

08435287160017

RPR-CARBON

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287160017
Basic UDI-DI: B-08435287160017
Reference: 36001
EMDN: W0105010301
EMDN description: SYPHILIS ANTIGEN DETECTION
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:51

Manufacturer products View details

08435287155587

CARBON DIOXIDE (CO2)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287155587
Basic UDI-DI: B-08435287155587
Reference: 21558
EMDN: W01010302
EMDN description: BICARBONATE
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:51

Manufacturer products View details

08435287148985

ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA-Formalin)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287148985
Basic UDI-DI: B-08435287148985
Reference: 44898
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:51

Manufacturer products View details

08435287148893

NEGATIVE CONTROL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287148893
Basic UDI-DI: B-08435287148893
Reference: 44889
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:51

Manufacturer products View details

08435287148855

ANTI-DEAMIDATED GLIADIN PEPTIDES IgA (DGP IgA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287148855
Basic UDI-DI: B-08435287148855
Reference: 44885
EMDN: W0102100699
EMDN description: CELIAC DISEASE - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:51

Manufacturer products View details

08435287148848

ANTI-DEAMIDATED GLIADIN PEPTIDES IgG (DGP IgG)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287148848
Basic UDI-DI: B-08435287148848
Reference: 44884
EMDN: W0102100699
EMDN description: CELIAC DISEASE - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:51

Manufacturer products View details

08435287148831

AStMA POSITIVE CONTROL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287148831
Basic UDI-DI: B-08435287148831
Reference: 44883
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:51

Manufacturer products View details

08435287148824

IgG FITC/EVANS (M)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287148824
Basic UDI-DI: B-08435287148824
Reference: 44882
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:51

Manufacturer products View details

08435287148787

ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA-Formalin)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287148787
Basic UDI-DI: B-08435287148787
Reference: 44878
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:51

Manufacturer products View details

08435287148749

AUTOANTIBODIES DUO-HEp2/ML (DUO-HEp2/ML)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287148749
Basic UDI-DI: B-08435287148749
Reference: 44874
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:51

Manufacturer products View details

08435287148732

ANTI-INSULIN ANTIBODIES (INS)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287148732
Basic UDI-DI: B-08435287148732
Reference: 44873
EMDN: W0102060199
EMDN description: DIABETES ASSAYS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:51

Manufacturer products View details

08435287148725

ASCA-IgG/IgA (ASCA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287148725
Basic UDI-DI: B-08435287148725
Reference: 44872
EMDN: W0102100801
EMDN description: SACCHAROMYCES CEREVISIAE ANTIBODIES
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:51

Manufacturer products View details

08435287148718

ANTI-M2 ANTIBODIES (M2)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287148718
Basic UDI-DI: B-08435287148718
Reference: 44871
EMDN: W0102100702
EMDN description: ANTI-MITOCHONDRIAL ANTIBODIES
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:51

Manufacturer products View details