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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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D-EIM4292505JA

Insulin & C-Peptide Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4292505JA
Basic UDI-DI: B-EIM4292505JA
Reference: EIM4292505
EMDN: W0102152008
EMDN description: CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES
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

D-EIM4292328JC

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

D-EIM4292327JA

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

D-EIM4292106HQ

Tumor Marker Control

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4292106HQ
Basic UDI-DI: B-EIM4292106HQ
Reference: EIM4292106
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
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

D-EIM4291507J7

Maternal Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4291507J7
Basic UDI-DI: B-EIM4291507J7
Reference: EIM4291507
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
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

D-EIM4291505J3

Insulin & C-Peptide Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4291505J3
Basic UDI-DI: B-EIM4291505J3
Reference: EIM4291505
EMDN: W0102152008
EMDN description: CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES
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

D-EIM4291332HU

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

D-EIM4291328J5

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

D-EIM4291327J3

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

D-EIM4291106HH

Tumor Marker Control

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4291106HH
Basic UDI-DI: B-EIM4291106HH
Reference: EIM4291106
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
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

D-EIM4284202HQ

Insulin Calibrators

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4284202HQ
Basic UDI-DI: B-EIM4284202HQ
Reference: EIM4284202
EMDN: W0102152208
EMDN description: STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS
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

D-EIM4284201HN

C-Peptide Calibrators

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4284201HN
Basic UDI-DI: B-EIM4284201HN
Reference: EIM4284201
EMDN: W0102152208
EMDN description: STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS
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

D-EIM4283332HX

HSV-1/2 IgM Calibrators

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4283332HX
Basic UDI-DI: B-EIM4283332HX
Reference: EIM4283332
EMDN: W0105080999
EMDN description: STANDARDS AND CALIBRATORS - 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

D-EIM4283328J8

HSV-2 IgG Calibrators

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4283328J8
Basic UDI-DI: B-EIM4283328J8
Reference: EIM4283328
EMDN: W0105080999
EMDN description: STANDARDS AND CALIBRATORS - 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

D-EIM4283327J6

HSV-1/2 IgG Calibrators

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4283327J6
Basic UDI-DI: B-EIM4283327J6
Reference: EIM4283327
EMDN: W0105080999
EMDN description: STANDARDS AND CALIBRATORS - 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

D-EIM4283202HH

Insulin Calibrators

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4283202HH
Basic UDI-DI: B-EIM4283202HH
Reference: EIM4283202
EMDN: W0102152208
EMDN description: STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS
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

D-EIM4283201HF

C-Peptide Calibrators

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4283201HF
Basic UDI-DI: B-EIM4283201HF
Reference: EIM4283201
EMDN: W0102152208
EMDN description: STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS
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

D-EIM4283057HY

Anti-thyroid peroxidase antibodies (Anti-TPO) Calibrators (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4283057HY
Basic UDI-DI: B-EIM4283057HY
Reference: EIM4283057
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - 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

D-EIM4283056HW

Anti-thyroglobulin antibodies (Anti-TG) Calibrators (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4283056HW
Basic UDI-DI: B-EIM4283056HW
Reference: EIM4283056
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - 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

D-EIM4283055HU

TSH Calibrators

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4283055HU
Basic UDI-DI: B-EIM4283055HU
Reference: EIM4283055
EMDN: W0102152202
EMDN description: HORMONE STANDARDS AND CALIBRATORS
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