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

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04.08.2026 14:01

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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

D-ECH01930057W

Total Bile Acids (TBA) Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01930057W
Basic UDI-DI: B-ECH01930057W
Reference: ECH0193005
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-ECH01925118B

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-ECH01925118B
Basic UDI-DI: B-ECH01925118B
Reference: ECH0192511
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 18:40

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01925028A

Assayed Multiple Chemistry Control (Multi-QC)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01925028A
Basic UDI-DI: B-ECH01925028A
Reference: ECH0192502
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
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-ECH019250188

Assayed Multiple Chemistry Control (Multi-QC)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH019250188
Basic UDI-DI: B-ECH019250188
Reference: ECH0192501
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
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-ECH01923518D

Homocysteine (Hcy) Control

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01923518D
Basic UDI-DI: B-ECH01923518D
Reference: ECH0192351
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-ECH01922188A

5′-Nucleotidase (5'-NT) Control

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01922188A
Basic UDI-DI: B-ECH01922188A
Reference: ECH0192218
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-ECH01922057Z

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-ECH01922057Z
Basic UDI-DI: B-ECH01922057Z
Reference: ECH0192205
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-ECH019220683

Adenosine Deaminase (ADA) Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH019220683
Basic UDI-DI: B-ECH019220683
Reference: ECH0192206
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-ECH01921047S

Glycosylated Hemoglobin A1c (HbA1c) Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01921047S
Basic UDI-DI: B-ECH01921047S
Reference: ECH0192104
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-ECH019206283

α1-Microglobulin (α1-MG) Control

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH019206283
Basic UDI-DI: B-ECH019206283
Reference: ECH0192062
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-ECH01920617Z

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-ECH01920617Z
Basic UDI-DI: B-ECH01920617Z
Reference: ECH0192061
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-ECH01920607X

Urinary Microalbumin (mAlb) Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01920607X
Basic UDI-DI: B-ECH01920607X
Reference: ECH0192060
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-ECH019205688

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-ECH019205688
Basic UDI-DI: B-ECH019205688
Reference: ECH0192056
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-ECH01920057P

Total Bile Acids (TBA) Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01920057P
Basic UDI-DI: B-ECH01920057P
Reference: ECH0192005
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-ECH019151184

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-ECH019151184
Basic UDI-DI: B-ECH019151184
Reference: ECH0191511
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 18:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01915017Z

Assayed Multiple Chemistry Control (Multi-QC)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01915017Z
Basic UDI-DI: B-ECH01915017Z
Reference: ECH0191501
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH019121883

5′-Nucleotidase (5'-NT) Control

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH019121883
Basic UDI-DI: B-ECH019121883
Reference: ECH0191218
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01912067U

Adenosine Deaminase (ADA) Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01912067U
Basic UDI-DI: B-ECH01912067U
Reference: ECH0191206
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01911047K

Glycosylated Hemoglobin A1c (HbA1c) Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01911047K
Basic UDI-DI: B-ECH01911047K
Reference: ECH0191104
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:39

Manufacturer products Authorised representative products Authorised representative actors View details