Public EUDAMED Search

EUDAMED Device Search

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

Last updated

07.07.2026 16:24

Sync status

Successful

Device

2707165

Actor

47334

Certificate

3045

Active filter:Manufacturer SRN:ES-MF-000000231

372 device results listed.

Page 2 / 19

08012992503782

IgA FITC/EVANS

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
Manufacturer
BIOSYSTEMS S.A.
Manufacturer SRN
ES-MF-000000231
UDI-DI
08012992503782
Basic UDI-DI
B-08012992503782
Reference
50378
EMDN
W01029099
EMDN description
IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country
Spain
Authorised representative
-
Last updated
07.07.2026 11:44
08012992503737

ASMA POSITIVE CONTROL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
BIOSYSTEMS S.A.
Manufacturer SRN
ES-MF-000000231
UDI-DI
08012992503737
Basic UDI-DI
B-08012992503737
Reference
50373
EMDN
W0102152003
EMDN description
SPECIFIC PROTEIN CONTROLS
First on market country
Spain
Authorised representative
-
Last updated
07.07.2026 11:44
08012992503720

AEA POSITIVE CONTROL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
BIOSYSTEMS S.A.
Manufacturer SRN
ES-MF-000000231
UDI-DI
08012992503720
Basic UDI-DI
B-08012992503720
Reference
44894
EMDN
W0102152003
EMDN description
SPECIFIC PROTEIN CONTROLS
First on market country
Spain
Authorised representative
-
Last updated
07.07.2026 11:44
08012992503713

AMA POSITIVE CONTROL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
BIOSYSTEMS S.A.
Manufacturer SRN
ES-MF-000000231
UDI-DI
08012992503713
Basic UDI-DI
B-08012992503713
Reference
50371
EMDN
W0102152003
EMDN description
SPECIFIC PROTEIN CONTROLS
First on market country
Spain
Authorised representative
-
Last updated
07.07.2026 11:44
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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