Glycated Hemoglobin Analyzer Column S

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref EC9404001

EMDN W0201060101

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-EC9404001B9 Basic UDI-DI	Date21 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 Analyzer Column S
Model / Reference: EC9404001

Primary DI / UDI-DI: D-EC9404001B9
Basic UDI-DI: B-EC9404001B9
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 254ff007-8edf-4cc5-b6ab-b4b70fdf64b7 61 fields · synced 22 Oct 2026