Creatine Kinase (CK)

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref ECH0101210

EMDN W01010113

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-ECH01012104G Basic UDI-DI	Date22 May 2022Registered	StatusActive

Coverage

1 jurisdiction

Expiring (legacy directive)
Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name: Creatine Kinase (CK)
Model / Reference: ECH0101210

Primary DI / UDI-DI: D-ECH01012104G
Basic UDI-DI: B-ECH01012104G
EMDN Code: W01010113 Creatine kinase - total

Device Class: Class IVD General
Market of Registration: Germany

Manufacturer details

EUDAMED SRN: CN-MF-000014618
Authorised representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties & raw data

Show properties, registry sources and raw records

Microbial Substances
Reagent
Professional Testing

Other properties (7)

Sterile: No
Human Tissues: No
Animal Tissues: No
Self Testing: No
Near-Patient Testing: No
Companion Diagnostics: No
Surgical Instrument: No

Sources (1)

EUDAMED bef2a226-b73d-45d9-b7d9-0dfe0b86f8bd 61 fields · synced 22 Oct 2026