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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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19.09.2026 21:25

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79 device results listed.

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HE0058N

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357043273
Basic UDI-DI: 08453570HE0058NZK
Reference: [HE0058N] Helix Elite™ Molecular Standards Negative Cellularity Control (Inactivated Pellet)
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

Multichem ID Multi-Marker Negative Control 2 x 4mL

Multichem ID Multi-Marker Negative Control 2 x 4mL

IVD Class BIVDR 2017/746On the marketHuman tissuesKitMicrobial substances

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00850041090917
Basic UDI-DI: 0816784020080XZ
Reference: 2010-0260
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 04:23

Manufacturer products Authorised representative products Authorised representative actors View details

anti-TP Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4292323L2
Basic UDI-DI: B-IM4292323L2
Reference: IM4292323
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:13

Manufacturer products Authorised representative products Authorised representative actors View details

anti-TP Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4291323KT
Basic UDI-DI: B-IM4291323KT
Reference: IM4291323
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:13

Manufacturer products Authorised representative products Authorised representative actors View details

AdvanSure™ i3 TB-IGRA Control

AdvanSure™ i3 TB-IGRA Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Invitros Co., Ltd
Manufacturer SRN: KR-MF-000023980
UDI-DI: D-IFC0002K00AR
Basic UDI-DI: B-IFC0002K00AR
Reference: IFC0002K00
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 14.07.2026 01:09

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-EIM4298328KN
Basic UDI-DI: B-EIM4298328KN
Reference: EIM4298328
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 18:57

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-EIM4298327KL
Basic UDI-DI: B-EIM4298327KL
Reference: EIM4298327
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 18:57

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-EIM4297332K6
Basic UDI-DI: B-EIM4297332K6
Reference: EIM4297332
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 18:57

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-EIM4297328KF
Basic UDI-DI: B-EIM4297328KF
Reference: EIM4297328
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-EIM4297327KD
Basic UDI-DI: B-EIM4297327KD
Reference: EIM4297327
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-EIM4295328JZ
Basic UDI-DI: B-EIM4295328JZ
Reference: EIM4295328
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-EIM4295327JX
Basic UDI-DI: B-EIM4295327JX
Reference: EIM4295327
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-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