α-Hydroxybutyrate Dehydrogenase (α-HBDH)

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref ECH0502354 EMDN W01010118

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-ECH050235474 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Withdrawn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 24 Oct 2026

Device Name: α-Hydroxybutyrate Dehydrogenase (α-HBDH)
Model / Reference: ECH0502354

Primary DI / UDI-DI: D-ECH050235474
Basic UDI-DI: B-ECH050235474
EMDN Code: W01010118 Hydroxybutyrate dehydrogenase

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

Microbial Substances
Reagent
Professional Testing

Other properties (7)

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

Sources (1)

EUDAMED 86f687e2-da7e-49b4-8b42-2ab9be388999 61 fields · synced 24 Oct 2026