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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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22.09.2026 20:14

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D-ECH05051577M

Apolipoprotein AⅠ (ApoAⅠ)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH05051577M
Basic UDI-DI: B-ECH05051577M
Reference: ECH0505157
EMDN: W0102010401
EMDN description: APOLIPOPROTEIN A I
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH050505378

Creatinine (Crea) Assay Kit by SAO Method

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH050505378
Basic UDI-DI: B-ECH050505378
Reference: ECH0505053
EMDN: W01010207
EMDN description: CREATININE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH05050076Z

Prealbumin (PA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH05050076Z
Basic UDI-DI: B-ECH05050076Z
Reference: ECH0505007
EMDN: W0102010305
EMDN description: PRE-ALBUMIN / TRANSTHYRETIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH050431476

Anti-Streptolysin O (ASO)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH050431476
Basic UDI-DI: B-ECH050431476
Reference: ECH0504314
EMDN: W01021104
EMDN description: ANTI-STREPTOLYSIN O (QUANTITATIVE)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH05043106W

Complement 4 (C4)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH05043106W
Basic UDI-DI: B-ECH05043106W
Reference: ECH0504310
EMDN: W0102010205
EMDN description: COMPLEMENT COMPONENT C4
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH05043097D

Complement 3 (C3)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH05043097D
Basic UDI-DI: B-ECH05043097D
Reference: ECH0504309
EMDN: W0102010203
EMDN description: COMPLEMENT COMPONENT C3/C3C
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH05043087B

Immunoglobulin M (IgM)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH05043087B
Basic UDI-DI: B-ECH05043087B
Reference: ECH0504308
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH050430779

Immunoglobulin A (IgA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH050430779
Basic UDI-DI: B-ECH050430779
Reference: ECH0504307
EMDN: W0102010101
EMDN description: IMMUNOGLOBULIN A
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH050430677

Immunoglobulin G (IgG)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH050430677
Basic UDI-DI: B-ECH050430677
Reference: ECH0505306
EMDN: W0102010105
EMDN description: IMMUNOGLOBULIN G
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH05042567H

Carbon Dioxide (CO2-cond)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH05042567H
Basic UDI-DI: B-ECH05042567H
Reference: ECH0504256
EMDN: W0101060601
EMDN description: CARBON DIOXIDE - ELECTRODES (BG)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH05042547D

Carbon Dioxide (CO2)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH05042547D
Basic UDI-DI: B-ECH05042547D
Reference: ECH0504254
EMDN: W0101060601
EMDN description: CARBON DIOXIDE - ELECTRODES (BG)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH050421879

5′-Nucleotidase (5'-NT)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH050421879
Basic UDI-DI: B-ECH050421879
Reference: ECH0504218
EMDN: W01010101
EMDN description: 5'-NUCLEOTIDASE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH050421777

Cholinesterase (ChE)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH050421777
Basic UDI-DI: B-ECH050421777
Reference: ECH0504217
EMDN: W01010111
EMDN description: CHOLINESTERASE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH050416379

Lipoprotein (a)(LP(a))

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH050416379
Basic UDI-DI: B-ECH050416379
Reference: ECH0504163
EMDN: W01010220
EMDN description: LIPOPROTEIN, CHEMICAL DETERMINATION/DETECTION
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH05041587G

Apolipoprotein B (ApoB)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH05041587G
Basic UDI-DI: B-ECH05041587G
Reference: ECH0504158
EMDN: W0102010403
EMDN description: APOLIPOPROTEIN B
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH05041577E

Apolipoprotein AⅠ (ApoAⅠ)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH05041577E
Basic UDI-DI: B-ECH05041577E
Reference: ECH0504157
EMDN: W0102010401
EMDN description: APOLIPOPROTEIN A I
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH050405575

β2-Microglobulin（β2-MG）

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH050405575
Basic UDI-DI: B-ECH050405575
Reference: ECH0504055
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH05033146X

Anti-Streptolysin O (ASO)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH05033146X
Basic UDI-DI: B-ECH05033146X
Reference: ECH0503314
EMDN: W01021104
EMDN description: ANTI-STREPTOLYSIN O (QUANTITATIVE)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH05033106P

Complement 4 (C4)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH05033106P
Basic UDI-DI: B-ECH05033106P
Reference: ECH0503310
EMDN: W0102010205
EMDN description: COMPLEMENT COMPONENT C4
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH05040536Z

Creatinine (Crea) Assay Kit by SAO Method

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH05040536Z
Basic UDI-DI: B-ECH05040536Z
Reference: ECH0504053
EMDN: W01010207
EMDN description: CREATININE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details