Glutamate Dehydrogenase (GLDH) Test Kit (Enzymatic)

by Biobase Biodustry(Shandong) Co., Ltd. China EUDAMED

Ref R1:64mL×2 R2:16mL×2（701）

EMDN W01010117

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	NumberB-06971674869146 Basic UDI-DI	Date27 Apr 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference: R1:64mL×2 R2:16mL×2（701）

Primary DI / UDI-DI: 06971674869146
Basic UDI-DI: B-06971674869146
EMDN Code: W01010117 Glutamate dehydrogenase

Device Class: Class IVD General
Market of Registration: Germany

Manufacturer details

EUDAMED SRN: CN-MF-000025015
Authorised representative: Luxus Lebenswelt GmbH DE-AR-000005110

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Properties & raw data

Show properties, registry sources and raw records

Reagent
Professional Testing

Other properties (8)

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

Sources (1)

EUDAMED 027a4d7f-85b3-4650-bca3-116c13f27168 61 fields · synced 22 Oct 2026