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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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17.09.2026 18:17

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171 device results listed.

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AESKULISA® alpha-Fodrin-Check

AESKULISA® alpha-Fodrin-Check

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500807
Basic UDI-DI: B-04250289500807
Reference: 3164
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:57

Manufacturer products View details

AESKULISA® alpha-Fodrin-G

AESKULISA® alpha-Fodrin-G

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500791
Basic UDI-DI: B-04250289500791
Reference: 3163
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:57

Manufacturer products View details

AESKULISA® alpha-Fodrin-A

AESKULISA® alpha-Fodrin-A

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500784
Basic UDI-DI: B-04250289500784
Reference: 3162
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:57

Manufacturer products View details

Aptiva® CTD Essential Reagent

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08430793040051
Basic UDI-DI: B-08430793040051
Reference: 723100
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 04:15

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-His Antibody CLIA Assay Kit

50 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424224568
Basic UDI-DI: B-06975424224568
Reference: CL30341E
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 04.08.2026 01:10

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-His Antibody CLIA Assay Kit

50 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424224551
Basic UDI-DI: B-06975424224551
Reference: CL20341E
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 04.08.2026 01:10

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, CENP-B

CENP-B, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030415587
Basic UDI-DI: B-06924030415587
Reference: MY00109C
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 09:09

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, PM-Scl

PM-Scl, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030415563
Basic UDI-DI: B-06924030415563
Reference: MY00107C
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 09:08

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, Ro52

Ro52, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030415532
Basic UDI-DI: B-06924030415532
Reference: MY00104C
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 09:08

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, Ro60

Ro60, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030415471
Basic UDI-DI: B-06924030415471
Reference: MY00098C
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 09:08

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Control Set, CENP-B

CENP-B, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030404284
Basic UDI-DI: B-06924030404284
Reference: MY00313
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 09:01

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Control Set, PCNA

PCNA, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030404253
Basic UDI-DI: B-06924030404253
Reference: MY00310
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 09:01

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Control Set, Ro52

Ro52, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030404239
Basic UDI-DI: B-06924030404239
Reference: MY00308
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 09:01

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Control Set, Ro60

Ro60, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030404178
Basic UDI-DI: B-06924030404178
Reference: MY00302
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 09:01

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Calibrator Set, CENP-B

CENP-B, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030403263
Basic UDI-DI: B-06924030403263
Reference: MY00211
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 09:00

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Calibrator Set, PCNA

PCNA, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030403232
Basic UDI-DI: B-06924030403232
Reference: MY00208
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 09:00

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Calibrator Set, Ro52

Ro52, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030403218
Basic UDI-DI: B-06924030403218
Reference: MY00206
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 09:00

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Calibrator Set, Ro60

Ro60, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030403157
Basic UDI-DI: B-06924030403157
Reference: MY00200
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 09:00

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, CENP-B

CENP-B, 100 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030402754
Basic UDI-DI: B-06924030402754
Reference: MY00160
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, PCNA

PCNA, 100 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030402723
Basic UDI-DI: B-06924030402723
Reference: MY00157
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