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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

22.09.2026 20:14

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53 device results listed.

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AESKULISA® LC-1

AESKULISA® LC-1

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289501620
Basic UDI-DI: B-04250289501620
Reference: 3702
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 11:22

Manufacturer products View details

2×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76356G5
Basic UDI-DI: B-DC76356G5
Reference: DC76356
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 06.08.2026 22:19

Manufacturer products Authorised representative products Authorised representative actors View details

2×25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76355G3
Basic UDI-DI: B-DC76355G3
Reference: DC76356
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 06.08.2026 22:19

Manufacturer products Authorised representative products Authorised representative actors View details

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76354FZ
Basic UDI-DI: B-DC76354FZ
Reference: DC76354
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 06.08.2026 22:19

Manufacturer products Authorised representative products Authorised representative actors View details

30 Tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76037FJ
Basic UDI-DI: B-DC76037FJ
Reference: DC76037
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 06.08.2026 22:16

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Control Set, gp210

gp210, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030404338
Basic UDI-DI: B-06924030404338
Reference: MY00318
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 14:14

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, SLA/LP

SLA/LP, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030415686
Basic UDI-DI: B-06924030415686
Reference: MY00119C
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - 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, LC-1

LC-1, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030415662
Basic UDI-DI: B-06924030415662
Reference: MY00117C
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - 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, gp210

gp210, 50 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030415631
Basic UDI-DI: B-06924030415631
Reference: MY00114C
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - 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 Control Set, SLA/LP

SLA/LP, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030404383
Basic UDI-DI: B-06924030404383
Reference: MY00323
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:04

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Control Set, AMA-M2

AMA-M2, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030404376
Basic UDI-DI: B-06924030404376
Reference: MY00322
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:04

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Control Set, LC-1

LC-1, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030404369
Basic UDI-DI: B-06924030404369
Reference: MY00321
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:04

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Calibrator Set, SLA/LP

SLA/LP, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030403362
Basic UDI-DI: B-06924030403362
Reference: MY00221
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - 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, AMA-M2

AMA-M2, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030403355
Basic UDI-DI: B-06924030403355
Reference: MY00220
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - 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, LC-1

LC-1, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030403348
Basic UDI-DI: B-06924030403348
Reference: MY00219
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - 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, gp210

gp210, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030403317
Basic UDI-DI: B-06924030403317
Reference: MY00216
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - 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, SLA/LP

SLA/LP, 100 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030402853
Basic UDI-DI: B-06924030402853
Reference: MY00170
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:59

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, AMA-M2

AMA-M2, 100 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030402846
Basic UDI-DI: B-06924030402846
Reference: MY00169
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:59

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, LC-1

LC-1, 100 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030402839
Basic UDI-DI: B-06924030402839
Reference: MY00168
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:59

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, gp210

gp210, 100 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030402808
Basic UDI-DI: B-06924030402808
Reference: MY00165
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:59

Manufacturer products Authorised representative products Authorised representative actors View details