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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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372 device results listed.

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08012992503706

NEGATIVE CONTROL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992503706
Basic UDI-DI: B-08012992503706
Reference: 50370
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:44

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08012992503690

ANA-Ho POSITIVE CONTROL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992503690
Basic UDI-DI: B-08012992503690
Reference: 50369
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:44

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08012992503683

C-ANCA POSITIVE CONTROL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992503683
Basic UDI-DI: B-08012992503683
Reference: 50368
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:44

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08012992503676

nDNA POSITIVE CONTROL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992503676
Basic UDI-DI: B-08012992503676
Reference: 50367
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:44

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08012992503669

P-ANCA POSITIVE CONTROL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992503669
Basic UDI-DI: B-08012992503669
Reference: 50366
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:44

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08012992500651

AUTOANTIBODIES-RL/RK/RS (AA-RL/RK/RS)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500651
Basic UDI-DI: B-08012992500651
Reference: 50065
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:44

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08012992500620

AUTOANTIBODIES MSL/MSK/MSS (AA-MSL/MSK/MSS)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500620
Basic UDI-DI: B-08012992500620
Reference: 50062
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

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08012992500613

AUTOANTIBODIES MSL/MSK/MSS (AA-MSL/MSK/MSS)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500613
Basic UDI-DI: B-08012992500613
Reference: 50061
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

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08012992500644

ANTI-nDNA ANTIBODIES (nDNA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500644
Basic UDI-DI: B-08012992500644
Reference: 50064
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

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08012992500637

ANTI-nDNA ANTIBODIES (nDNA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500637
Basic UDI-DI: B-08012992500637
Reference: 50063
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

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08012992500606

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: 08012992500606
Basic UDI-DI: B-08012992500606
Reference: 50060
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

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08012992500590

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: 08012992500590
Basic UDI-DI: B-08012992500590
Reference: 50059
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

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08012992500583

ANTI-ENDOMYSIUM ANTIBODIES (AEA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500583
Basic UDI-DI: B-08012992500583
Reference: 50058
EMDN: W0102100603
EMDN description: ANTIBODIES TO ENDOMYSIAL AUTOANTIGENES
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

Manufacturer products View details

08012992500576

ANTI-ENDOMYSIUM ANTIBODIES (AEA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500576
Basic UDI-DI: B-08012992500576
Reference: 50057
EMDN: W0102100603
EMDN description: ANTIBODIES TO ENDOMYSIAL AUTOANTIGENES
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

Manufacturer products View details

08012992500569

ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA-Formalin)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500569
Basic UDI-DI: B-08012992500569
Reference: 50056
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

Manufacturer products View details

08012992500552

ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA-Formalin)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500552
Basic UDI-DI: B-08012992500552
Reference: 50055
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

Manufacturer products View details

08012992500545

ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500545
Basic UDI-DI: B-08012992500545
Reference: 50054
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

Manufacturer products View details

08012992500538

ANTI-NEUTROPHIL CYTOPLASMIC ANTBODIES (ANCA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500538
Basic UDI-DI: B-08012992500538
Reference: 50053
EMDN: W0102100499
EMDN description: VASCULITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

Manufacturer products View details

08012992500521

AUTOANTIBODIES-RL/RK/RS (AA-RL/RK/RS)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08012992500521
Basic UDI-DI: B-08012992500521
Reference: 50052
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 11:43

Manufacturer products View details

03610522158263

AEA IgG POSITIVE CONTROL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 03610522158263
Basic UDI-DI: B-03610522158263
Reference: 12012273
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 05.07.2026 17:01

Manufacturer products View details