Hematology Analyzer Fluorescent Platelets Control

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref EBL2203101

EMDN W0103010505

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-EBL22031017U Basic UDI-DI	Date25 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 23 Oct 2026

Device Name: Hematology Analyzer Fluorescent Platelets Control
Model / Reference: EBL2203101

Primary DI / UDI-DI: D-EBL22031017U
Basic UDI-DI: B-EBL22031017U
EMDN Code: W0103010505 Platelet controls

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

Animal Tissues
Professional Testing

Other properties (8)

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

Sources (1)

EUDAMED 485e1f9b-3fc2-45fd-b0b0-183cc5ed5cc6 61 fields · synced 23 Oct 2026