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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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67 device results listed.

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HSV-1/2 IgM Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4294332JH
Basic UDI-DI: B-EIM4294332JH
Reference: EIM4294332
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

HSV-2 IgG Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4294328JS
Basic UDI-DI: B-EIM4294328JS
Reference: EIM4294328
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

HSV-1/2 IgG Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4294327JQ
Basic UDI-DI: B-EIM4294327JQ
Reference: EIM4294327
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

HSV-2 IgG Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4292328JC
Basic UDI-DI: B-EIM4292328JC
Reference: EIM4292328
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

HSV-1/2 IgG Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4292327JA
Basic UDI-DI: B-EIM4292327JA
Reference: EIM4292327
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

HSV-1/2 IgM Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4291332HU
Basic UDI-DI: B-EIM4291332HU
Reference: EIM4291332
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

HSV-2 IgG Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4291328J5
Basic UDI-DI: B-EIM4291328J5
Reference: EIM4291328
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

HSV-1/2 IgG Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4291327J3
Basic UDI-DI: B-EIM4291327J3
Reference: EIM4291327
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

Access CMV IgM QC

Access CMV IgM QC

IVD Annex II List BIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A40707U4
Basic UDI-DI: B-A40707U4
Reference: A40707
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

Access CMV IgG QC

Access CMV IgG QC

IVD Annex II List BIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A40704TW
Basic UDI-DI: B-A40704TW
Reference: A40704
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

Access Toxo IgG QC

Access Toxo IgG QC

IVD Annex II List BIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-A31590U3
Basic UDI-DI: B-A31590U3
Reference: A31590
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 12.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

Vigil Serology Control Level C

Vigil Serology Control Level C

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-465440QG
Basic UDI-DI: B-465440QG
Reference: 465440
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

Access RUBELLA IgM QC

Access RUBELLA IgM QC

IVD Annex II List BIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34449GV
Basic UDI-DI: B-34449GV
Reference: 34449
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

Polyvalent negative control, 1 x 1 mL

Polyvalent negative control, 1 x 1 mL

IVD generalIVDDOn the marketAnimal tissuesKitReagentSingle use

Manufacturer: Chronolab Systems, S.L.
Manufacturer SRN: ES-MF-000017043
UDI-DI: D-084360385415413EF
Basic UDI-DI: B-084360385415413EF
Reference: 101-0107
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:29

Manufacturer products View details

Polyvalent positive control, 1 x 1 mL

Polyvalent positive control, 1 x 1 mL

IVD generalIVDDOn the marketAnimal tissuesKitReagentSingle use

Manufacturer: Chronolab Systems, S.L.
Manufacturer SRN: ES-MF-000017043
UDI-DI: D-084360385405406E7
Basic UDI-DI: B-084360385405406E7
Reference: 101-0106
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 08.07.2026 00:29

Manufacturer products View details

Multichem ID ToRCH IgG Negative Control

2010-0023

IVD Annex II List BIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850041090016
Basic UDI-DI: B-00850041090016
Reference: 2010-0023
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 05.07.2026 11:02

Manufacturer products Authorised representative products Authorised representative actors View details

A1 Negative Control

2010-0013

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00816784021007
Basic UDI-DI: B-00816784021007
Reference: 2010-0013
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 04.07.2026 21:42

Manufacturer products Authorised representative products Authorised representative actors View details

ACCURUN 803 Nucleic Acid Negative Quality Control

2035-0007

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00816784020710
Basic UDI-DI: B-00816784020710
Reference: 2035-0007
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 04.07.2026 21:42

Manufacturer products Authorised representative products Authorised representative actors View details

A810 Negative Control

2010-0020

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00816784020246
Basic UDI-DI: B-00816784020246
Reference: 2010-0020
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 04.07.2026 21:40

Manufacturer products Authorised representative products Authorised representative actors View details

ACCURUN 800 ToRCH Negative Control

2010-0018

IVD Annex II List BIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00816784020239
Basic UDI-DI: B-00816784020239
Reference: 2010-0018
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 04.07.2026 21:40

Manufacturer products Authorised representative products Authorised representative actors View details