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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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IDS SS-A/Ro 52 kDa

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169693807
Basic UDI-DI: B-05060169693807
Reference: IS-AI1103
EMDN: W0102100112
EMDN description: SS-A
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 02.08.2026 17:59

Manufacturer products Authorised representative products Authorised representative actors View details

IDS SS-A/Ro

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169693791
Basic UDI-DI: B-05060169693791
Reference: IS-AI1102
EMDN: W0102100112
EMDN description: SS-A
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 02.08.2026 17:59

Manufacturer products Authorised representative products Authorised representative actors View details

IDS dsDNA IgG

IDS dsDNA igG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169693784
Basic UDI-DI: B-05060169693784
Reference: IS-AI1101
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 02.08.2026 17:59

Manufacturer products Authorised representative products Authorised representative actors View details

IDS ENA Screen

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169693777
Basic UDI-DI: B-05060169693777
Reference: IS-AI1002
EMDN: W0102100102
EMDN description: ENA SCREENING
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 02.08.2026 17:59

Manufacturer products Authorised representative products Authorised representative actors View details

IDS ANA Screen

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169693760
Basic UDI-DI: B-05060169693760
Reference: IS-AI1001
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 02.08.2026 17:59

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Ribosomal P IgG CLIA Microparticles

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359545389
Basic UDI-DI: 697015090000312H6
Reference: CMQ2205
EMDN: W0102100118
EMDN description: RIBOSOMAL PHOSPHOPROTEIN ANTIBODIES
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:03

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-nRNP/Sm IgG CLIA Microparticles

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IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359545280
Basic UDI-DI: 697015090000311H4
Reference: CMQ2105
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:03

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Scl-70 IgG CLIA Microparticles

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IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359544986
Basic UDI-DI: 697015090000308HF
Reference: CMQ1805
EMDN: W0102100110
EMDN description: SCL-70
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:03

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Sm IgG CLIA Microparticles

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359545181
Basic UDI-DI: 697015090000310H2
Reference: CMQ2005
EMDN: W0102100111
EMDN description: SM
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:03

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-SS-B IgG CLIA Microparticles

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IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359544887
Basic UDI-DI: 697015090000307HD
Reference: CMQ0905
EMDN: W0102100113
EMDN description: SS-B
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:03

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Ro-52 IgG CLIA Microparticles

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359544788
Basic UDI-DI: 697015090000306HB
Reference: CMQ0805
EMDN: W0102100112
EMDN description: SS-A
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:03

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-SS-A/Ro IgG CLIA Microparticles

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359544689
Basic UDI-DI: 697015090000305H9
Reference: CMQ0705
EMDN: W0102100112
EMDN description: SS-A
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:03

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Ribosomal P IgG CLIA Microparticles

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359545365
Basic UDI-DI: 697015090000312H6
Reference: CMQ2203
EMDN: W0102100118
EMDN description: RIBOSOMAL PHOSPHOPROTEIN ANTIBODIES
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-nRNP/Sm IgG CLIA Microparticles

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359545266
Basic UDI-DI: 697015090000311H4
Reference: CMQ2103
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Sm IgG CLIA Microparticles

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359545167
Basic UDI-DI: 697015090000310H2
Reference: CMQ2003
EMDN: W0102100111
EMDN description: SM
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Jo-1 IgG CLIA Microparticles

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359545068
Basic UDI-DI: 697015090000309HH
Reference: CMQ1903
EMDN: W0102100108
EMDN description: JO-1
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Scl-70 IgG CLIA Microparticles

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359544962
Basic UDI-DI: 697015090000308HF
Reference: CMQ1803
EMDN: W0102100110
EMDN description: SCL-70
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-SS-B IgG CLIA Microparticles

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359544863
Basic UDI-DI: 697015090000307HD
Reference: CMQ0903
EMDN: W0102100113
EMDN description: SS-B
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Ro-52 IgG CLIA Microparticles

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359544764
Basic UDI-DI: 697015090000306HB
Reference: CMQ0803
EMDN: W0102100112
EMDN description: SS-A
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-SS-A/Ro IgG CLIA Microparticles

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359544665
Basic UDI-DI: 697015090000305H9
Reference: CMQ0703
EMDN: W0102100112
EMDN description: SS-A
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details