Myocardial Enzyme Reagent Kit (CK +3 more)

EUDAMED

Class IVD General (EU MDR)

Ref 1T001

by Changsha Sinocare Inc.

Identity

Device Name: Myocardial Enzyme Reagent Kit (CK, CK-MB, LDH, α -HBDH) EUDAMED
Model / Reference: 1T001 EUDAMED

Identifiers

Primary DI / UDI-DI: D-02B0011YE EUDAMED
Basic UDI-DI: B-02B0011YE EUDAMED
EMDN Code: W01010118,W01010121,W0102160701 EUDAMED
Models / Variants: CK EUDAMED
CK-MB EUDAMED
LDH EUDAMED
α -HBDH EUDAMED

Classification

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

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

Yes

EUDAMED

Professional Testing

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Myocardial Enzyme Reagent Kit (CK +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-02B0011YE	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 a62abe90-a99d-4413-8eae-4c015aa37881 61 fields · synced Oct 6, 2026