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EUDAMED Device Search

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TREN

Last updated

21.09.2026 19:21

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Device

3157640

Actor

47652

Certificate

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Active filter:EMDN:W0102100701

10 device results listed.

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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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView details
IDS LKM-1

IDS LKM-1

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
Manufacturer
Immunodiagnostic Systems Limited
Manufacturer SRN
GB-MF-000015851
UDI-DI
05060169694026
Basic UDI-DI
B-05060169694026
Reference
IS-AI1802
EMDN
W0102100701
EMDN description
HEPATITIS AUTOANTIBODY SCREENING
First on market country
Belgium
Authorised representative
Immunodiagnostic Systems SA
Last updated
02.08.2026 18:00
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
QUANTA Lite

QUANTA Lite® Actin IgG ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use
Manufacturer
Inova Diagnostics. Inc.
Manufacturer SRN
US-MF-000017851
UDI-DI
08426950485094
Basic UDI-DI
B-08426950485094
Reference
708785
EMDN
W0102100701
EMDN description
HEPATITIS AUTOANTIBODY SCREENING
First on market country
Italy
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
07.07.2026 23:18
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
AESKUBLOTS® Liver Pro

AESKUBLOTS® Liver Pro

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use
Manufacturer
Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN
DE-MF-000026925
UDI-DI
04250289504546
Basic UDI-DI
B-04250289504546
Reference
4004
EMDN
W0102100701
EMDN description
HEPATITIS AUTOANTIBODY SCREENING
First on market country
Germany
Authorised representative
-
Last updated
06.07.2026 07:39
Manufacturer productsView details
CHORUS MACROARRAY LIVER DISEASES

ALDSC

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use
Manufacturer
DIESSE Diagnostica Senese S.p.A
Manufacturer SRN
IT-MF-000013311
UDI-DI
08033891322625
Basic UDI-DI
803389132ALDSC00D3
Reference
80800
EMDN
W0102100701
EMDN description
HEPATITIS AUTOANTIBODY SCREENING
First on market country
Italy
Authorised representative
-
Last updated
03.07.2026 08:15
Manufacturer productsView details
06950617403791

IM4410470 IM4411470 IM4414470 IM4415470

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent
Manufacturer
Maccura Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000014618
UDI-DI
06950617403791
Basic UDI-DI
69506174IM441470E4
Reference
IM4415470
EMDN
W0102100701
EMDN description
HEPATITIS AUTOANTIBODY SCREENING
First on market country
Spain
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
28.06.2026 08:42
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06950617403784

IM4410470 IM4411470 IM4414470 IM4415470

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent
Manufacturer
Maccura Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000014618
UDI-DI
06950617403784
Basic UDI-DI
69506174IM441470E4
Reference
IM4414470
EMDN
W0102100701
EMDN description
HEPATITIS AUTOANTIBODY SCREENING
First on market country
Spain
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
28.06.2026 08:42
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06950617403777

IM4410470 IM4411470 IM4414470 IM4415470

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent
Manufacturer
Maccura Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000014618
UDI-DI
06950617403777
Basic UDI-DI
69506174IM441470E4
Reference
IM4411470
EMDN
W0102100701
EMDN description
HEPATITIS AUTOANTIBODY SCREENING
First on market country
Spain
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
28.06.2026 08:42
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06950617403760

IM4410470 IM4411470 IM4414470 IM4415470

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent
Manufacturer
Maccura Biotechnology Co., Ltd.
Manufacturer SRN
CN-MF-000014618
UDI-DI
06950617403760
Basic UDI-DI
69506174IM441470E4
Reference
IM4410470
EMDN
W0102100701
EMDN description
HEPATITIS AUTOANTIBODY SCREENING
First on market country
Spain
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
28.06.2026 08:42
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details