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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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23.09.2026 22:40

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813 device results listed.

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BioCLIA Autoimmune Reagent Kit, Ribosomal P

Ribosomal P, 100 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030402716
Basic UDI-DI: B-06924030402716
Reference: MY00156
EMDN: W0102100118
EMDN description: RIBOSOMAL PHOSPHOPROTEIN ANTIBODIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, Ro52

Ro52, 100 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030402709
Basic UDI-DI: B-06924030402709
Reference: MY00155
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, Scl-70

Scl-70, 100 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030402693
Basic UDI-DI: B-06924030402693
Reference: MY00154
EMDN: W0102100110
EMDN description: SCL-70
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, Jo-1

Jo-1, 100 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030402686
Basic UDI-DI: B-06924030402686
Reference: MY00153
EMDN: W0102100108
EMDN description: JO-1
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, Sm

Sm, 100 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030402679
Basic UDI-DI: B-06924030402679
Reference: MY00152
EMDN: W0102100111
EMDN description: SM
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, nRNP/Sm

nRNP/Sm, 100 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030402662
Basic UDI-DI: B-06924030402662
Reference: MY00151
EMDN: W0102100114
EMDN description: U1-SNRNP - ANTIBODIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, SS-B/La

SS-B/La, 100 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030402655
Basic UDI-DI: B-06924030402655
Reference: MY00150
EMDN: W0102100113
EMDN description: SS-B
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, Ro60

Ro60, 100 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030402648
Basic UDI-DI: B-06924030402648
Reference: MY00149
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, dsDNA

dsDNA,100 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030402631
Basic UDI-DI: B-06924030402631
Reference: MY00148
EMDN: W0102100105
EMDN description: DS DNA - ANTIBODIES
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

Line Immuno Assay (LIA) for the Detection of Antinuclear Antibodies

ENA-7, 16 Tests

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030400965
Basic UDI-DI: B-06924030400965
Reference: MB00176
EMDN: W0102100102
EMDN description: ENA SCREENING
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

Line Immuno Assay (LIA) for the Detection of Antinuclear Antibodies

ANA-9, 16 Tests

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030400958
Basic UDI-DI: B-06924030400958
Reference: MB00175
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

Line Immuno Assay (LIA) for the Detection of Antinuclear Antibodies

ANA-13, 16 Tests

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030400941
Basic UDI-DI: B-06924030400941
Reference: MB00174
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

Line Immuno Assay (LIA) for the Detection of Antinuclear Antibodies

ANA-15, 16 Tests

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030400934
Basic UDI-DI: B-06924030400934
Reference: MB00173
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Türkiye
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:58

Manufacturer products Authorised representative products Authorised representative actors View details

Myositis Profile 12 Ag OJ Dot for BDI

542502368BDDMYOSITISTF

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681770
Basic UDI-DI: B-05425023681770
Reference: AD MYOSO12ADBD
EMDN: W0102100108
EMDN description: JO-1
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:46

Manufacturer products View details

Myositis Profile 12 Ag OJ Dot

542502368BDMYOSITIS74

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680834
Basic UDI-DI: B-05425023680834
Reference: AD MYOSO12AD
EMDN: W0102100108
EMDN description: JO-1
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:45

Manufacturer products View details

BlueDot ANA12 Screen IgG

BlueDot

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023680339
Basic UDI-DI: B-05425023680339
Reference: ANA12SD-24
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:45

Manufacturer products View details

IDS CCP

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169694019
Basic UDI-DI: B-05060169694019
Reference: IS-AI1201
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 02.08.2026 18:00

Manufacturer products Authorised representative products Authorised representative actors View details

IDS Jo-1

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169693869
Basic UDI-DI: B-05060169693869
Reference: IS-AI1109
EMDN: W0102100110
EMDN description: SCL-70
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 Scl-70

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169693852
Basic UDI-DI: B-05060169693852
Reference: IS-AI1108
EMDN: W0102100110
EMDN description: SCL-70
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 U1-snRNP

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169693845
Basic UDI-DI: B-05060169693845
Reference: IS-AI1107
EMDN: W0102100114
EMDN description: U1-SNRNP - ANTIBODIES
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