GLU/HDL-C/TC/TG Combo test kit

EUDAMED

Class IVD General (EU MDR)

Ref GLU/HDL-C/TC/TG

by Hunan Ehome Health Technology Company Limited

Identity

Trade Name: GLU/HDL-C/TC/TG Combo test kit EUDAMED
Device Name: GLU/HDL-C/TC/TG Combo test kit EUDAMED
Model / Reference: GLU/HDL-C/TC/TG EUDAMED

Identifiers

Primary DI / UDI-DI: 06975679490534 EUDAMED
Basic UDI-DI: B-06975679490534 EUDAMED
EMDN Code: W01021499 MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: France EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

GLU/HDL-C/TC/TG Combo test kit by Hunan Ehome Health Technology Company Limited — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	B-06975679490534	Class IVD General	Active

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Manufacturer

Manufacturer: Hunan Ehome Health Technology Company Limited
EUDAMED SRN: CN-MF-000045177
Authorised Representative: Medunion S.L. ES-AR-000019366

Sources (1)

EUDAMED 2dfa84b8-fa83-4f65-8fd1-0674adfbc52b 61 fields · synced Jun 18, 2026