Glycated Hemoglobin Analyzer Column S

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref EC9403001 EMDN W0201060101

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-EC9403001B2 Basic UDI-DI	Date21 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Withdrawn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 25 Oct 2026

Device Name: Glycated Hemoglobin Analyzer Column S
Model / Reference: EC9403001

Primary DI / UDI-DI: D-EC9403001B2
Basic UDI-DI: B-EC9403001B2
EMDN Code: W0201060101 Glycosilated hemoglobin devices

Device Class: Class IVD General
Market of Registration: Spain

Manufacturer details

EUDAMED SRN: CN-MF-000014618
Authorised representative: Humiss International B.V. NL-AR-000001490

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Properties & raw data

Show properties, registry sources and raw records

Professional Testing

Other properties (9)

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

Sources (1)

EUDAMED a03afb78-7a6d-405a-ab4c-3939b534a6f6 61 fields · synced 25 Oct 2026