Glycated Hemoglobin A1c Control

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref BL2592002

EMDN W0101050205

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-BL2592002DU 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: Glycated Hemoglobin A1c Control
Model / Reference: BL2592002

Primary DI / UDI-DI: D-BL2592002DU
Basic UDI-DI: B-BL2592002DU
EMDN Code: W0101050205 Diabetes 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 ba5842e5-203d-43b0-b30c-eaf0d951ec03 61 fields · synced 22 Oct 2026