Homocysteine (HCY) Test Kit (Enzymatic)

EUDAMED

Class IVD General (EU MDR)

Ref R1:20mL×4 R2:6.5mL×4（709）

by Biobase Biodustry(Shandong) Co., Ltd.

Identity

Trade Name: Homocysteine (HCY) Test Kit (Enzymatic) EUDAMED
Device Name: Homocysteine (HCY) Test Kit (Enzymatic) EUDAMED
Model / Reference: R1:20mL×4 R2:6.5mL×4（709） EUDAMED

Identifiers

Primary DI / UDI-DI: 06971674868606 EUDAMED
Basic UDI-DI: B-06971674868606 EUDAMED
EMDN Code: W01021307 HOMOCYSTEINE EUDAMED

Classification

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

Homocysteine (HCY) Test Kit (Enzymatic) by Biobase Biodustry(Shandong) Co., Ltd. — 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-06971674868606	Class IVD General	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Biobase Biodustry(Shandong) Co., Ltd.
EUDAMED SRN: CN-MF-000025015
Authorised Representative: Luxus Lebenswelt GmbH DE-AR-000005110

Sources (1)

EUDAMED 5469c1e8-9a66-4a61-bbb1-814257548a89 61 fields · synced Oct 5, 2026