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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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816 device results listed.

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Sharay Anti-SS-A IgG (CLIA)

Sharay Anti-SS-A IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070761066
Basic UDI-DI: B-06975070761066
Reference: 18105001
EMDN: W0102100112
EMDN description: SS-A
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-Sm IgG (CLIA)

Sharay Anti-Sm IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070761059
Basic UDI-DI: B-06975070761059
Reference: 18116001
EMDN: W0102100111
EMDN description: SM
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-Scl-70 IgG (CLIA)

Sharay Anti-Scl-70 IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070761042
Basic UDI-DI: B-06975070761042
Reference: 18113001
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-nRNP/Sm IgG (CLIA)

Sharay Anti-nRNP/Sm IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070761028
Basic UDI-DI: B-06975070761028
Reference: 18117001
EMDN: W0102100114
EMDN description: U1-SNRNP - ANTIBODIES
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-Jo-1 IgG (CLIA)

Sharay Anti-Jo-1 IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070760991
Basic UDI-DI: B-06975070760991
Reference: 18115001
EMDN: W0102100108
EMDN description: JO-1
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-dsDNA IgG (CLIA)

Sharay Anti-dsDNA IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070760984
Basic UDI-DI: B-06975070760984
Reference: 18118001
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay Anti-CENP-B IgG (CLIA)

Sharay Anti-CENP-B IgG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070760977
Basic UDI-DI: B-06975070760977
Reference: 18109001
EMDN: W0102100115
EMDN description: ANTI-CENTROMERE ANTIBODIES
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

Sharay ANA Screen (CLIA)

Sharay ANA Screen (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070760953
Basic UDI-DI: B-06975070760953
Reference: 18149001
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 21:33

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-dsDNA IgG Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）

200 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Diagnostic Technology (Shandong) Co., Ltd.
Manufacturer SRN: CN-MF-000025964
UDI-DI: 06974969982995
Basic UDI-DI: B-06974969982995
Reference: 200 Tests/kit（DR1158-3）
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 21:17

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-dsDNA IgG Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）

100 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Diagnostic Technology (Shandong) Co., Ltd.
Manufacturer SRN: CN-MF-000025964
UDI-DI: 06974969982988
Basic UDI-DI: B-06974969982988
Reference: 100 Tests/kit（DR1158-2）
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 21:17

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-dsDNA IgG Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）

50 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Diagnostic Technology (Shandong) Co., Ltd.
Manufacturer SRN: CN-MF-000025964
UDI-DI: 06974969982971
Basic UDI-DI: B-06974969982971
Reference: 50 Tests/kit（DR1158-1）
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 21:17

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-nuclear Antibodies (ANA) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）

200 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Diagnostic Technology (Shandong) Co., Ltd.
Manufacturer SRN: CN-MF-000025964
UDI-DI: 06974969982841
Basic UDI-DI: B-06974969982841
Reference: 200 Tests/kit（DR1137-3）
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 21:17

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-nuclear Antibodies (ANA) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）

100 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Diagnostic Technology (Shandong) Co., Ltd.
Manufacturer SRN: CN-MF-000025964
UDI-DI: 06974969982834
Basic UDI-DI: B-06974969982834
Reference: 100 Tests/kit（DR1137-2）
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 21:17

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-nuclear Antibodies (ANA) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）

50 Tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biobase Diagnostic Technology (Shandong) Co., Ltd.
Manufacturer SRN: CN-MF-000025964
UDI-DI: 06974969982827
Basic UDI-DI: B-06974969982827
Reference: 50 Tests/kit（DR1137-1）
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 21:17

Manufacturer products Authorised representative products Authorised representative actors View details

ANA Screen FIA Kit

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892244
Basic UDI-DI: B-06974674892244
Reference: 18-02-0054
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:13

Manufacturer products Authorised representative products Authorised representative actors View details

ENA Screen FIA Kit

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892251
Basic UDI-DI: B-06974674892251
Reference: 18-02-0055
EMDN: W0102100102
EMDN description: ENA SCREENING
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:13

Manufacturer products Authorised representative products Authorised representative actors View details

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000022829
UDI-DI: 06974674892237
Basic UDI-DI: B-06974674892237
Reference: 18-02-0053
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:13

Manufacturer products Authorised representative products Authorised representative actors View details

Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle ) 50tests/kit

IVD generalIVDDOn the marketKitReagent

Manufacturer: Nanjing RealMind Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000024838
UDI-DI: 06972719607280
Basic UDI-DI: B-06972719607280
Reference: 50tests/kit
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Hungary
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 06.07.2026 15:56

Manufacturer products Authorised representative products Authorised representative actors View details

Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )50tests/kit

IVD generalIVDDOn the marketKitReagent

Manufacturer: Nanjing RealMind Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000024838
UDI-DI: 06972719607273
Basic UDI-DI: B-06972719607273
Reference: 50tests/kit
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Hungary
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 06.07.2026 15:56

Manufacturer products Authorised representative products Authorised representative actors View details

Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )50tests/kit

IVD generalIVDDOn the marketKitReagent

Manufacturer: Nanjing RealMind Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000024838
UDI-DI: 06972719607266
Basic UDI-DI: B-06972719607266
Reference: 50tests/kit
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Hungary
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 06.07.2026 15:56

Manufacturer products Authorised representative products Authorised representative actors View details