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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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336 device results listed.

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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 Autoantibodies in Autoimmune Liver Diseases

Liver-4, 16 Tests

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030401009
Basic UDI-DI: B-06924030401009
Reference: MB00180
EMDN: W0102100701
EMDN description: HEPATITIS AUTOANTIBODY 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 Autoantibodies in Autoimmune Liver Diseases

Liver-8, 16 Tests

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030400996
Basic UDI-DI: B-06924030400996
Reference: MB00179
EMDN: W0102100701
EMDN description: HEPATITIS AUTOANTIBODY 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 Antibodies in Autoimmune Vasculitis

Vasculitis-2, 16 Tests

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030400989
Basic UDI-DI: B-06924030400989
Reference: MB00178
EMDN: W0102100401
EMDN description: ANCA 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 Antibodies in Autoimmune Vasculitis

Vasculitis-3, 16 Tests

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030400972
Basic UDI-DI: B-06924030400972
Reference: MB00177
EMDN: W0102100401
EMDN description: ANCA 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

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

BioCLIA Autoimmune Reagent Kit, Cardiolipin IgA

BioCLIA Autoimmune Reagent Kit, BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control Set

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030416409
Basic UDI-DI: 6924030BioCLIAAI3N
Reference: MY02197C
EMDN: W0102109099
EMDN description: AUTO-IMMUNE DISEASE TESTS - OTHER
First on market country: Croatia
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 18:22

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA System Wash Buffer

Sample Diluent I, System Wash Buffer,System Substrate

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030405199
Basic UDI-DI: 6924030BioCLIACR4E
Reference: MY00404
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 18:22

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, Mi-2

BioCLIA Autoimmune Reagent Kit, BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control Set

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030416836
Basic UDI-DI: 6924030BioCLIAAI3N
Reference: MY02274
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Spain
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 10:28

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, IgG4

-

IVD Class BNot specifiedOn the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030416966
Basic UDI-DI: 6924030BioCLIAAI3N
Reference: MY02291
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 29.06.2026 23:00

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, IgG4

-

IVD Class BNot specifiedOn the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030416959
Basic UDI-DI: 6924030BioCLIAAI3N
Reference: MY02292C
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 29.06.2026 23:00

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Calibrator Set, IgG4

-

IVD Class BNot specifiedOn the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030416973
Basic UDI-DI: 6924030BioCLIAAI3N
Reference: MY02293
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 29.06.2026 23:00

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Calibrator Set, IgG4

-

IVD Class BNot specifiedNot intended for EU marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030416980
Basic UDI-DI: 6924030BioCLIAAI3N
Reference: MY02295
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 29.06.2026 23:00

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Control Set, IgG4

-

IVD Class BNot specifiedOn the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030416997
Basic UDI-DI: 6924030BioCLIAAI3N
Reference: MY02294
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 29.06.2026 23:00

Manufacturer products Authorised representative products Authorised representative actors View details