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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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04.08.2026 02:01

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D-ECH01955118Y

Lipid & Immunology Multiple (LIM) Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01955118Y
Basic UDI-DI: B-ECH01955118Y
Reference: ECH0195511
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH019535192

Homocysteine (Hcy) Control

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH019535192
Basic UDI-DI: B-ECH019535192
Reference: ECH0195351
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01952188X

5′-Nucleotidase (5'-NT) Control

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01952188X
Basic UDI-DI: B-ECH01952188X
Reference: ECH0195218
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01951048F

Glycosylated Hemoglobin A1c (HbA1c) Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01951048F
Basic UDI-DI: B-ECH01951048F
Reference: ECH0195104
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01950608L

Urinary Microalbumin (mAlb) Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01950608L
Basic UDI-DI: B-ECH01950608L
Reference: ECH0195060
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01950568V

Cystatin C (Cys C) Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01950568V
Basic UDI-DI: B-ECH01950568V
Reference: ECH0195056
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01945118R

Lipid & Immunology Multiple (LIM) Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01945118R
Basic UDI-DI: B-ECH01945118R
Reference: ECH0194511
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01942188Q

5′-Nucleotidase (5'-NT) Control

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01942188Q
Basic UDI-DI: B-ECH01942188Q
Reference: ECH0194218
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH019410488

Glycosylated Hemoglobin A1c (HbA1c) Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH019410488
Basic UDI-DI: B-ECH019410488
Reference: ECH0194104
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01940628H

α1-Microglobulin (α1-MG) Control

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01940628H
Basic UDI-DI: B-ECH01940628H
Reference: ECH0194062
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01940618F

Neutrophil Gelatinase-associated Lipocalin (NGAL) Control

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01940618F
Basic UDI-DI: B-ECH01940618F
Reference: ECH0194061
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01940608D

Urinary Microalbumin (mAlb) Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01940608D
Basic UDI-DI: B-ECH01940608D
Reference: ECH0194060
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH019400585

Total Bile Acids (TBA) Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH019400585
Basic UDI-DI: B-ECH019400585
Reference: ECH0194005
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01935118J

Lipid & Immunology Multiple (LIM) Control

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01935118J
Basic UDI-DI: B-ECH01935118J
Reference: ECH0193511
EMDN: W0101050199
EMDN description: MULTICOMPONENT CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01932188H

5′-Nucleotidase (5'-NT) Control

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01932188H
Basic UDI-DI: B-ECH01932188H
Reference: ECH0193218
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH019320588

α-L-Fucosidase (AFU) Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH019320588
Basic UDI-DI: B-ECH019320588
Reference: ECH0193205
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:40

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01931047Z

Glycosylated Hemoglobin A1c (HbA1c) Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01931047Z
Basic UDI-DI: B-ECH01931047Z
Reference: ECH0193104
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:40

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01930628A

α1-Microglobulin (α1-MG) Control

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01930628A
Basic UDI-DI: B-ECH01930628A
Reference: ECH0193062
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:40

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH019306188

Neutrophil Gelatinase-associated Lipocalin (NGAL) Control

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH019306188
Basic UDI-DI: B-ECH019306188
Reference: ECH0193061
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:40

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01930568F

Cystatin C (Cys C) Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01930568F
Basic UDI-DI: B-ECH01930568F
Reference: ECH0193056
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:40

Manufacturer products Authorised representative products Authorised representative actors View details