← Back to catalogue

Multiple (9 Items) Cardiac Marker Kit (Microfluidic Fluorescent Immunoassay)

EUDAMED

Class IVD General (EU MDR)

Ref /

by Hunan Kangxin Biotechnology Co., Ltd.

Identity

Device Name
Multiple (9 Items) Cardiac Marker Kit (Microfluidic Fluorescent Immunoassay) EUDAMED
Model / Reference
/ EUDAMED

Identifiers

Primary DI / UDI-DI
D-TD-HNKX-CED-364A EUDAMED
Basic UDI-DI
B-TD-HNKX-CED-364A EUDAMED
EMDN Code
W01021399 CARDIAC MARKERS - OTHER EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Spain EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Multiple (9 Items) Cardiac Marker Kit (Microfluidic Fluorescent Immunoassay) by Hunan Kangxin Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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

Manufacturer

Manufacturer
Hunan Kangxin Biotechnology Co., Ltd.
EUDAMED SRN
CN-MF-000020121
Authorised Representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (1)

  • EUDAMED 74a7bb4a-6f0a-429d-833b-f26004788e08 61 fields · synced Jul 20, 2026