Glycated Hemoglobin A1c (HPLC) Kit

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref BL2509001 EMDN W01010214

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-BL2509001C8 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Withdrawn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 25 Oct 2026

Device Name: Glycated Hemoglobin A1c (HPLC) Kit
Model / Reference: BL2509001

Primary DI / UDI-DI: D-BL2509001C8
Basic UDI-DI: B-BL2509001C8
EMDN Code: W01010214 Glycosylated/glycated haemoglobin (cc)

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

Other devices from Maccura Biotechnology Co., Ltd.

Magnesium Assay Kit (Xylidyl Blue Method)

Class B
Automatic Hematology Analyzer F-DC Diluent

Class A
γ-Glutamyltransferase Assay Kit (Glycylglycine Cyanide Anilide Method)

Class B
Lactic Acid Assay Kit (Lactate Oxidase Method)

Class B
Cholinesterase Assay Kit (Butyrylthiocholine Substrate Method)

Class B
Lactate Dehydrogenase Assay Kit (Lactate Substrate Method)

Class B

See all devices from Maccura Biotechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records

Animal Tissues
Reagent
Professional Testing

Other properties (7)

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

Sources (1)

EUDAMED 80d6f6e7-de35-4700-9e30-0098d6f76cf9 61 fields · synced 25 Oct 2026