Blood Lipid Reagent Kit (TC +3 more)

EUDAMED

Class IVD General (EU MDR)

Ref 1J001

by Changsha Sinocare Inc.

Identity

Device Name: Blood Lipid Reagent Kit (TC/TG/HDL-C/LDL-C) EUDAMED
Model / Reference: 1J001 EUDAMED

Identifiers

Primary DI / UDI-DI: D-02B0012YG EUDAMED
Basic UDI-DI: B-02B0012YG EUDAMED
EMDN Code: W01010205,W01010215,W01010221,W01010231 EUDAMED
Models / Variants: TC EUDAMED
TG EUDAMED
HDL-C EUDAMED
LDL-C 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

Yes

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

Yes

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Blood Lipid Reagent Kit (TC +3 more) by Changsha Sinocare Inc. — Class IVD General — IVDD — listed in EUDAMED — 4 models — 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-02B0012YG	Class IVD General	Active

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Manufacturer

Manufacturer: Changsha Sinocare Inc.
EUDAMED SRN: CN-MF-000012244
Authorised Representative: Lotus NL B.V. NL-AR-000000121

Sources (1)

EUDAMED 254b1a16-9588-457a-a3d0-76158054ab5c 61 fields · synced Jul 11, 2026