Cardiac Troponin I Reagent Kit

EUDAMED

Class IVD General (EU MDR)

Ref cTnI6011Y, cTnI6012Y, cTnI6013Y, cTnI6014Y, cTnI6015Y, cTnI6011N, cTnI6012N, cTnI6013N, cTnI6014N, cTnI6015N

by Hangzhou Aichek Medical Technology Co., Ltd.

Identity

Trade Name: Cardiac Troponin I Reagent Kit EUDAMED
Device Name: Cardiac Troponin I Reagent Kit EUDAMED
Model / Reference: cTnI6011Y, cTnI6012Y, cTnI6013Y, cTnI6014Y, cTnI6015Y, cTnI6011N, cTnI6012N, cTnI6013N, cTnI6014N, cTnI6015N EUDAMED

Identifiers

Primary DI / UDI-DI: D-cTnI601RE EUDAMED
Basic UDI-DI: B-cTnI601RE EUDAMED
EMDN Code: W01021306 TROPONIN I/T EUDAMED

Classification

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

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Cardiac Troponin I Reagent Kit by Hangzhou Aichek Medical Technology 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-cTnI601RE	Class IVD General	Active

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Manufacturer

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
EUDAMED SRN: CN-MF-000028093
Authorised Representative: Medunion S.L. ES-AR-000019366

Sources (2)

EUDAMED 03ff8f46-d230-4198-9b5f-99feadb79f0e-1 61 fields · synced Oct 6, 2026
EUDAMED 03ff8f46-d230-4198-9b5f-99feadb79f0e-2 61 fields · synced Jul 16, 2026