Coagulation Quality Control Plasma (CQC)

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref EBL2197001 EMDN W0103020702

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-EBL2197001B9 Basic UDI-DI	Date22 May 2022Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name: Coagulation Quality Control Plasma (CQC)
Model / Reference: EBL2197001

Primary DI / UDI-DI: D-EBL2197001B9
Basic UDI-DI: B-EBL2197001B9
EMDN Code: W0103020702 Control plasma for haemostasis

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

Human Tissues
Animal Tissues
Professional Testing

Other properties (7)

Sterile: No
Microbial Substances: No
Reagent: No
Self Testing: No
Near-Patient Testing: No
Companion Diagnostics: No
Surgical Instrument: No

Sources (1)

EUDAMED cda50d09-6326-411b-b061-70a01bcf095a 61 fields · synced 24 Oct 2026