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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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22.09.2026 16:13

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153 device results listed.

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EliA LKM-1 Well

EliA LKM-1

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066020600
Basic UDI-DI: 7333066BUDI0027M2
Reference: 14-6648-01
EMDN: W0102100703
EMDN description: LKM1 AND RELATED PROTEINS ANTIBODIES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:18

Manufacturer products View details

EliA Parietal Cell Well

EliA Parietal Cell

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066015781
Basic UDI-DI: 7333066BUDI0125M3
Reference: 14-5669-01
EMDN: W0102100705
EMDN description: PARIETAL CELL ANTIBODIES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:17

Manufacturer products View details

EliA M2

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066014852
Basic UDI-DI: 7333066BUDI0121LT
Reference: 14-5649-01
EMDN: W0102100702
EMDN description: ANTI-MITOCHONDRIAL ANTIBODIES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:16

Manufacturer products View details

Liver Profile Dot for BDI

-

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023687475
Basic UDI-DI: 542502368BDDLIVERKL
Reference: AD LIVERDBD
EMDN: W0102100703
EMDN description: LKM1 AND RELATED PROTEINS ANTIBODIES
First on market country: Belgium
Authorised representative: -
Last updated: 30.06.2026 22:48

Manufacturer products View details

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 products Authorised representative products Authorised representative actors View details

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 products Authorised representative products Authorised representative actors View details

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 products Authorised representative products Authorised representative actors View details

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 products Authorised representative products Authorised representative actors View details

IM4410468 IM4411468 IM4414468 IM4415468

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403753
Basic UDI-DI: 69506174IM441468EH
Reference: IM4415468
EMDN: W0102100703
EMDN description: LKM1 AND RELATED PROTEINS ANTIBODIES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:42

Manufacturer products Authorised representative products Authorised representative actors View details

IM4410468 IM4411468 IM4414468 IM4415468

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403746
Basic UDI-DI: 69506174IM441468EH
Reference: IM4414468
EMDN: W0102100703
EMDN description: LKM1 AND RELATED PROTEINS ANTIBODIES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:42

Manufacturer products Authorised representative products Authorised representative actors View details

IM4410468 IM4411468 IM4414468 IM4415468

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403739
Basic UDI-DI: 69506174IM441468EH
Reference: IM4411468
EMDN: W0102100703
EMDN description: LKM1 AND RELATED PROTEINS ANTIBODIES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:42

Manufacturer products Authorised representative products Authorised representative actors View details

IM4410468 IM4411468 IM4414468 IM4415468

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403722
Basic UDI-DI: 69506174IM441468EH
Reference: IM4410468
EMDN: W0102100703
EMDN description: LKM1 AND RELATED PROTEINS ANTIBODIES
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:42

Manufacturer products Authorised representative products Authorised representative actors View details

IM4410458 IM4411458 IM4414458 IM4415458

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403715
Basic UDI-DI: 69506174IM441458EE
Reference: IM4415458
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:42

Manufacturer products Authorised representative products Authorised representative actors View details

IM4410458 IM4411458 IM4414458 IM4415458

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403708
Basic UDI-DI: 69506174IM441458EE
Reference: IM4414458
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:42

Manufacturer products Authorised representative products Authorised representative actors View details

IM4410458 IM4411458 IM4414458 IM4415458

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403692
Basic UDI-DI: 69506174IM441458EE
Reference: IM4411458
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:42

Manufacturer products Authorised representative products Authorised representative actors View details

IM4410458 IM4411458 IM4414458 IM4415458

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403685
Basic UDI-DI: 69506174IM441458EE
Reference: IM4410458
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:42

Manufacturer products Authorised representative products Authorised representative actors View details

IM4410471 IM4411471 IM4414471 IM4415471

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403593
Basic UDI-DI: 69506174IM441471E6
Reference: IM4410471
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:42

Manufacturer products Authorised representative products Authorised representative actors View details

IM4410471 IM4411471 IM4414471 IM4415471

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403586
Basic UDI-DI: 69506174IM441471E6
Reference: IM4410471
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:42

Manufacturer products Authorised representative products Authorised representative actors View details

IM4410471 IM4411471 IM4414471 IM4415471

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403579
Basic UDI-DI: 69506174IM441471E6
Reference: IM4410471
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:42

Manufacturer products Authorised representative products Authorised representative actors View details

IM4410471 IM4411471 IM4414471 IM4415471

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617403562
Basic UDI-DI: 69506174IM441471E6
Reference: IM4410471
EMDN: W0102100799
EMDN description: AUTOIMMUNE HEPATITIS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:42

Manufacturer products Authorised representative products Authorised representative actors View details