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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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777 device results listed.

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NOVA Lite

NOVA Lite® ANA KSL Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950506324
Basic UDI-DI: B-08426950506324
Reference: 708390
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:18

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Lite

QUANTA Lite® Histone ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950506331
Basic UDI-DI: B-08426950506331
Reference: 708520
EMDN: W0102100107
EMDN description: HISTONES (H1, H2A, H3, H4,…HN)
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:18

Manufacturer products Authorised representative products Authorised representative actors View details

NOVA Lite

NOVA Lite® HEp-2 ANA Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950456193
Basic UDI-DI: B-08426950456193
Reference: 708100
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:18

Manufacturer products Authorised representative products Authorised representative actors View details

NOVA Lite

NOVA Lite® dsDNA Crithidia lucilae

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950455882
Basic UDI-DI: B-08426950455882
Reference: 708200
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:18

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Lite

QUANTA Lite® dsDNA ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950454502
Basic UDI-DI: B-08426950454502
Reference: 708510
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:18

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Lite

QUANTA Lite® ANA ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950454373
Basic UDI-DI: B-08426950454373
Reference: 708750
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:18

Manufacturer products Authorised representative products Authorised representative actors View details

08034049110958

Anti dsDNA IgG

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Dia.Metra Srl
Manufacturer SRN: IT-MF-000027206
UDI-DI: 08034049110958
Basic UDI-DI: B-08034049110958
Reference: DKO095
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 18:01

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products View details

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

Manufacturer products View details

Sharay Anti-U1-RNP (CLIA)

50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06980070460550
Basic UDI-DI: B-06980070460550
Reference: 14000877
EMDN: W0102100114
EMDN description: U1-SNRNP - ANTIBODIES
First on market country: Ireland
Authorised representative: Sungo Cert GmbH
Last updated: 07.07.2026 02:53

Manufacturer products Authorised representative products Authorised representative actors View details

06976043630129

SM Antibody Detection Kit

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: iCarbonX IntelliCore (Guangdong) Co., Ltd.
Manufacturer SRN: CN-MF-000045482
UDI-DI: 06976043630129
Basic UDI-DI: B-06976043630129
Reference: 012
EMDN: W0102100111
EMDN description: SM
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

06976043630105

dsDNA IgG Rapid Kit

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: iCarbonX IntelliCore (Guangdong) Co., Ltd.
Manufacturer SRN: CN-MF-000045482
UDI-DI: 06976043630105
Basic UDI-DI: B-06976043630105
Reference: 010
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

06976043630068

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: iCarbonX IntelliCore (Guangdong) Co., Ltd.
Manufacturer SRN: CN-MF-000045482
UDI-DI: 06976043630068
Basic UDI-DI: B-06976043630068
Reference: 006
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

06976043630051

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: iCarbonX IntelliCore (Guangdong) Co., Ltd.
Manufacturer SRN: CN-MF-000045482
UDI-DI: 06976043630051
Basic UDI-DI: B-06976043630051
Reference: 005
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

06976043630044

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: iCarbonX IntelliCore (Guangdong) Co., Ltd.
Manufacturer SRN: CN-MF-000045482
UDI-DI: 06976043630044
Basic UDI-DI: B-06976043630044
Reference: 004
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Netherlands
Authorised representative: Kingsmead Service B.V.
Last updated: 07.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-His Antibody CLIA Assay Kit

100 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424226999
Basic UDI-DI: B-06975424226999
Reference: CL30342EN
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Nuc Antibody CLIA Assay Kit

100 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424226982
Basic UDI-DI: B-06975424226982
Reference: CL30332EN
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Jo-1 Antibody CLIA Assay Kit

100 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424226975
Basic UDI-DI: B-06975424226975
Reference: CL30312EN
EMDN: W0102100108
EMDN description: JO-1
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details