- Manufacturer
- Autobio Diagnostics Co., Ltd.
- Manufacturer SRN
- CN-MF-000003348
- UDI-DI
- 06942359544184
- Basic UDI-DI
- 697015090000326HH
- Reference
- CMQ3305
- EMDN
- W0102100101
- EMDN description
- ANA SCREENING
- First on market country
- Italy
- Authorised representative
- QbD RepS BV
- Last updated
- 08.07.2026 19:47
Public EUDAMED Search
EUDAMED Device Search
A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.
Last updated
01.08.2026 18:27
Sync status
Successful
Device
2990209
Actor
47523
Certificate
3174
IVD Class BNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
IVD Class BNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- Autobio Diagnostics Co., Ltd.
- Manufacturer SRN
- CN-MF-000003348
- UDI-DI
- 06942359545082
- Basic UDI-DI
- 697015090000309HH
- Reference
- CMQ1905
- EMDN
- W0102100108
- EMDN description
- JO-1
- First on market country
- France
- Authorised representative
- QbD RepS BV
- Last updated
- 08.07.2026 19:47
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
08435287148701
ANTI-GBM ANTIBODIES-EIA (GBM)
IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- BIOSYSTEMS S.A.
- Manufacturer SRN
- ES-MF-000000231
- UDI-DI
- 08435287148701
- Basic UDI-DI
- B-08435287148701
- Reference
- 44870
- EMDN
- W0102100199
- EMDN description
- AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
- First on market country
- Spain
- Authorised representative
- -
- Last updated
- 07.07.2026 23:51
08435287148695
ANTI-ANNEXIN V IgG/IgM (ANX)
IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- BIOSYSTEMS S.A.
- Manufacturer SRN
- ES-MF-000000231
- UDI-DI
- 08435287148695
- Basic UDI-DI
- B-08435287148695
- Reference
- 44869
- EMDN
- W0102100199
- EMDN description
- AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
- First on market country
- Spain
- Authorised representative
- -
- Last updated
- 07.07.2026 23:51
08435287148688
ANTI-beta-2-GLYCOPROTEIN 1 IgG/IgM (betaGP1)
IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- BIOSYSTEMS S.A.
- Manufacturer SRN
- ES-MF-000000231
- UDI-DI
- 08435287148688
- Basic UDI-DI
- B-08435287148688
- Reference
- 44868
- EMDN
- W0102100199
- EMDN description
- AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
- First on market country
- Spain
- Authorised representative
- -
- Last updated
- 07.07.2026 23:51
08435287148657
ANTI-CENTROMERE B ANTIBODIES (CENP-B)
IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- BIOSYSTEMS S.A.
- Manufacturer SRN
- ES-MF-000000231
- UDI-DI
- 08435287148657
- Basic UDI-DI
- B-08435287148657
- Reference
- 44865
- EMDN
- W0102100115
- EMDN description
- ANTI-CENTROMERE ANTIBODIES
- First on market country
- Spain
- Authorised representative
- -
- Last updated
- 07.07.2026 23:51
08435287148626
ANTI-HISTONES ANTIBODIES (HIS)
IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- BIOSYSTEMS S.A.
- Manufacturer SRN
- ES-MF-000000231
- UDI-DI
- 08435287148626
- Basic UDI-DI
- B-08435287148626
- Reference
- 44862
- EMDN
- W0102100107
- EMDN description
- HISTONES (H1, H2A, H3, H4,…HN)
- First on market country
- Spain
- Authorised representative
- -
- Last updated
- 07.07.2026 23:51
08435287148619
ANTI-NUCLEOSOME ANTIBODIES (NCL)
IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- BIOSYSTEMS S.A.
- Manufacturer SRN
- ES-MF-000000231
- UDI-DI
- 08435287148619
- Basic UDI-DI
- B-08435287148619
- Reference
- 44861
- EMDN
- W0102100117
- EMDN description
- NUCLEOSOME ANTIBODIES
- First on market country
- Spain
- Authorised representative
- -
- Last updated
- 07.07.2026 23:50
08435287148251
ANTI-nDNA ANTIBODIES (nDNA)
IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- BIOSYSTEMS S.A.
- Manufacturer SRN
- ES-MF-000000231
- UDI-DI
- 08435287148251
- Basic UDI-DI
- B-08435287148251
- Reference
- 44825
- EMDN
- W0102100105
- EMDN description
- DS DNA - ANTIBODIES
- First on market country
- Spain
- Authorised representative
- -
- Last updated
- 07.07.2026 23:50
08435287148206
ANTI-nDNA ANTIBODIES (nDNA)
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent
- Manufacturer
- BIOSYSTEMS S.A.
- Manufacturer SRN
- ES-MF-000000231
- UDI-DI
- 08435287148206
- Basic UDI-DI
- B-08435287148206
- Reference
- 44820
- EMDN
- W0102100105
- EMDN description
- DS DNA - ANTIBODIES
- First on market country
- Spain
- Authorised representative
- -
- Last updated
- 07.07.2026 23:50
08435287148190
ANTI-nDNA ANTIBODIES (nDNA)
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent
- Manufacturer
- BIOSYSTEMS S.A.
- Manufacturer SRN
- ES-MF-000000231
- UDI-DI
- 08435287148190
- Basic UDI-DI
- B-08435287148190
- Reference
- 44819
- EMDN
- W0102100105
- EMDN description
- DS DNA - ANTIBODIES
- First on market country
- Spain
- Authorised representative
- -
- Last updated
- 07.07.2026 23:50
08435287148183
ANTI-nDNA ANTIBODIES (nDNA)
IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- BIOSYSTEMS S.A.
- Manufacturer SRN
- ES-MF-000000231
- UDI-DI
- 08435287148183
- Basic UDI-DI
- B-08435287148183
- Reference
- 44818
- EMDN
- W0102100105
- EMDN description
- DS DNA - ANTIBODIES
- First on market country
- Spain
- Authorised representative
- -
- Last updated
- 07.07.2026 23:50
08435287148176
ANTI-nDNA ANTIBODIES (nDNA)
IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- BIOSYSTEMS S.A.
- Manufacturer SRN
- ES-MF-000000231
- UDI-DI
- 08435287148176
- Basic UDI-DI
- B-08435287148176
- Reference
- 44817
- EMDN
- W0102100105
- EMDN description
- DS DNA - ANTIBODIES
- First on market country
- Spain
- Authorised representative
- -
- Last updated
- 07.07.2026 23:50
08435287147964
ANTI-THYROGLOBULIN ANTIBODIES (ANTI-Tg)
IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- BIOSYSTEMS S.A.
- Manufacturer SRN
- ES-MF-000000231
- UDI-DI
- 08435287147964
- Basic UDI-DI
- B-08435287147964
- Reference
- 44796
- EMDN
- W0102100199
- EMDN description
- AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
- First on market country
- Spain
- Authorised representative
- -
- Last updated
- 07.07.2026 23:50
08435287147858
ANA-SCREENING
IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- BIOSYSTEMS S.A.
- Manufacturer SRN
- ES-MF-000000231
- UDI-DI
- 08435287147858
- Basic UDI-DI
- B-08435287147858
- Reference
- 44785
- EMDN
- W0102100101
- EMDN description
- ANA SCREENING
- First on market country
- Spain
- Authorised representative
- -
- Last updated
- 07.07.2026 23:50
08435287147803
ANTI-CARDIOLIPIN ANTIBODIES (ACA-IgG/IgM)
IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- BIOSYSTEMS S.A.
- Manufacturer SRN
- ES-MF-000000231
- UDI-DI
- 08435287147803
- Basic UDI-DI
- B-08435287147803
- Reference
- 44780
- EMDN
- W0102100199
- EMDN description
- AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
- First on market country
- Spain
- Authorised representative
- -
- Last updated
- 07.07.2026 23:50
08435287147704
ANTI-Sm/RNP ANTIBODIES
IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- BIOSYSTEMS S.A.
- Manufacturer SRN
- ES-MF-000000231
- UDI-DI
- 08435287147704
- Basic UDI-DI
- B-08435287147704
- Reference
- 44770
- EMDN
- W0102100199
- EMDN description
- AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
- First on market country
- Spain
- Authorised representative
- -
- Last updated
- 07.07.2026 23:50
08435287147650
ANTI-SSA (Ro) ANTIBODIES
IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- BIOSYSTEMS S.A.
- Manufacturer SRN
- ES-MF-000000231
- UDI-DI
- 08435287147650
- Basic UDI-DI
- B-08435287147650
- Reference
- 44765
- EMDN
- W0102100199
- EMDN description
- AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
- First on market country
- Spain
- Authorised representative
- -
- Last updated
- 07.07.2026 23:50
08435287147506
ANTI-SS-B (La) ANTIBODIES
IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- BIOSYSTEMS S.A.
- Manufacturer SRN
- ES-MF-000000231
- UDI-DI
- 08435287147506
- Basic UDI-DI
- B-08435287147506
- Reference
- 44750
- EMDN
- W0102100199
- EMDN description
- AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
- First on market country
- Spain
- Authorised representative
- -
- Last updated
- 07.07.2026 23:49