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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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24.09.2026 00:57

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40 device results listed.

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ARCHITECT

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740009359
Basic UDI-DI: 038074ARC0630K2
Reference: 06C3020
EMDN: W0105080902
EMDN description: HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 02:26

Manufacturer products View details

Alinity

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740131333
Basic UDI-DI: 038074AIP0826LF
Reference: 08P2622
EMDN: W0105080902
EMDN description: HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 02:26

Manufacturer products View details

ARCHITECT

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740164683
Basic UDI-DI: 038074ARC0630K2
Reference: 06C3075
EMDN: W0105080902
EMDN description: HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 01:57

Manufacturer products View details

ARCHITECT

IVD Class BIVDR 2017/746Not intended for EU marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740164669
Basic UDI-DI: 038074ARC0630K2
Reference: 06C3019
EMDN: W0105080902
EMDN description: HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 01:57

Manufacturer products View details

ARCHITECT

IVD Class BIVDR 2017/746Not intended for EU marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740164676
Basic UDI-DI: 038074ARC0630K2
Reference: 06C3074
EMDN: W0105080902
EMDN description: HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 01:33

Manufacturer products View details

Alinity

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740131326
Basic UDI-DI: 038074AIP0826LF
Reference: 08P2610
EMDN: W0105080902
EMDN description: HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 01:33

Manufacturer products View details

ARCHITECT

IVD Class BIVDR 2017/746Not intended for EU marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740164614
Basic UDI-DI: 038074ARC0629KH
Reference: 06C2909
EMDN: W0105080902
EMDN description: HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 01:33

Manufacturer products View details

Alinity

IVD Class BIVDR 2017/746Not intended for EU marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740163570
Basic UDI-DI: 038074AIR0228LB
Reference: 02R2819
EMDN: W0105080902
EMDN description: HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 01:33

Manufacturer products View details

Alinity

IVD Class BIVDR 2017/746Not intended for EU marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740163563
Basic UDI-DI: 038074AIR0228LB
Reference: 02R2809
EMDN: W0105080902
EMDN description: HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 01:33

Manufacturer products View details

Alinity

IVD Class BIVDR 2017/746Not intended for EU marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740163600
Basic UDI-DI: 038074AIR0228LB
Reference: 02R2877
EMDN: W0105080902
EMDN description: HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 01:33

Manufacturer products View details

ARCHITECT

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740164645
Basic UDI-DI: 038074ARC0629KH
Reference: 06C2975
EMDN: W0105080902
EMDN description: HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 01:33

Manufacturer products View details

ARCHITECT

IVD Class BIVDR 2017/746Not intended for EU marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740164621
Basic UDI-DI: 038074ARC0629KH
Reference: 06C2919
EMDN: W0105080902
EMDN description: HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 01:32

Manufacturer products View details

Alinity

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740135065
Basic UDI-DI: 038074AIR0228LB
Reference: 02R2810
EMDN: W0105080902
EMDN description: HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 01:30

Manufacturer products View details

Alinity

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740131340
Basic UDI-DI: 038074AIP0826LF
Reference: 08P2632
EMDN: W0105080902
EMDN description: HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 01:30

Manufacturer products View details

ARCHITECT

IVD Class BIVDR 2017/746Not intended for EU marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740164652
Basic UDI-DI: 038074ARC0630K2
Reference: 06C3009
EMDN: W0105080902
EMDN description: HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 01:30

Manufacturer products View details

ARCHITECT

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740009342
Basic UDI-DI: 038074ARC0630K2
Reference: 06C3010
EMDN: W0105080902
EMDN description: HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 01:28

Manufacturer products View details

D-IM4291315KU

HAV IgM Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4291315KU
Basic UDI-DI: B-IM4291315KU
Reference: IM4291315
EMDN: W0105080902
EMDN description: HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:13

Manufacturer products Authorised representative products Authorised representative actors View details

Access HBc IgM (Reagent Pack)

IVD Annex II List AIVDDOn the marketMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34250G4
Basic UDI-DI: B-34250G4
Reference: 34250
EMDN: W0105080902
EMDN description: HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

Access anti-HAV IgM Calibrator

C39448

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590745134
Basic UDI-DI: 150995901C39448SE
Reference: C39448
EMDN: W0105080902
EMDN description: HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:40

Manufacturer products Authorised representative products Authorised representative actors View details

Access anti-HAV Calibrator

C39445

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590745103
Basic UDI-DI: 150995901C39445S8
Reference: C39445
EMDN: W0105080902
EMDN description: HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details