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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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17.07.2026 09:39

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high sensitive C-reactive protein (hs-CRP) Assay Kit by Fluorescence Immunochromatographic Method

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4101076EH
Basic UDI-DI: B-EIM4101076EH
Reference: EIM4101076
EMDN: W01021308
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin (PCT) Assay Kit by Fluorescence Immunochromatographic Method

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4101071E7
Basic UDI-DI: B-EIM4101071E7
Reference: EIM4101071
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Fluorescent PCR Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EGN7105110FC
Basic UDI-DI: B-EGN7105110FC
Reference: EGN7105110
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Fluorescent PCR Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EGN7104117FK
Basic UDI-DI: B-EGN7104117FK
Reference: EGN7104117
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Fluorescent PCR Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EGN7104110F5
Basic UDI-DI: B-EGN7104110F5
Reference: EGN7104110
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Fluorescent PCR Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EGN7103117FC
Basic UDI-DI: B-EGN7103117FC
Reference: EGN7103117
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Fluorescent PCR

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EGN7102109F6
Basic UDI-DI: B-EGN7102109F6
Reference: EGN7102109
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Fluorescent PCR

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EGN7103109FD
Basic UDI-DI: B-EGN7103109FD
Reference: EGN7103109
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Fluorescent PCR Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EGN7102117F5
Basic UDI-DI: B-EGN7102117F5
Reference: EGN7102117
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Fluorescent PCR Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EGN7101117EW
Basic UDI-DI: B-EGN7101117EW
Reference: EGN7101117
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:47

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Fluorescent PCR

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EGN7101109EX
Basic UDI-DI: B-EGN7101109EX
Reference: EGN7101109
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:46

Manufacturer products Authorised representative products Authorised representative actors View details

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-ECH050905384
Basic UDI-DI: B-ECH050905384
Reference: ECH0509053
EMDN: W01010207
EMDN description: CREATININE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:46

Manufacturer products Authorised representative products Authorised representative actors View details

Prealbumin (PA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH05090077V
Basic UDI-DI: B-ECH05090077V
Reference: ECH0509007
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 18:46

Manufacturer products Authorised representative products Authorised representative actors View details

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-ECH05080537V
Basic UDI-DI: B-ECH05080537V
Reference: ECH0508053
EMDN: W01010207
EMDN description: CREATININE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:46

Manufacturer products Authorised representative products Authorised representative actors View details

Prealbumin (PA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH05080077N
Basic UDI-DI: B-ECH05080077N
Reference: ECH0508007
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 18:46

Manufacturer products Authorised representative products Authorised representative actors View details

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-ECH05070537N
Basic UDI-DI: B-ECH05070537N
Reference: ECH0507053
EMDN: W01010207
EMDN description: CREATININE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:46

Manufacturer products Authorised representative products Authorised representative actors View details

Prealbumin (PA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH05070077F
Basic UDI-DI: B-ECH05070077F
Reference: ECH0507007
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 18:46

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Streptolysin O (ASO)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH05063147L
Basic UDI-DI: B-ECH05063147L
Reference: ECH0506314
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 18:46

Manufacturer products Authorised representative products Authorised representative actors View details

Complement 4 (C4)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH05063107C
Basic UDI-DI: B-ECH05063107C
Reference: ECH0506310
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 18:46

Manufacturer products Authorised representative products Authorised representative actors View details

Complement 3 (C3)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH05063097T
Basic UDI-DI: B-ECH05063097T
Reference: ECH0506309
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 18:46

Manufacturer products Authorised representative products Authorised representative actors View details