Creatine Kinase Isoenzyme -MB Test (Fluorescence Immunoassay)

EUDAMED

Class IVD General (EU MDR)

Ref 1001029

by Huzhou Jierunxin Biotechnology Co., LTD

Identity

Device Name: Creatine Kinase Isoenzyme -MB Test (Fluorescence Immunoassay) EUDAMED
Model / Reference: 1001029 EUDAMED

Identifiers

Primary DI / UDI-DI: 06979878281351 EUDAMED
Basic UDI-DI: B-06979878281351 EUDAMED
EMDN Code: W01021311 CREATINE KINASE - MB MASS (IC) EUDAMED

Classification

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

Creatine Kinase Isoenzyme -MB Test (Fluorescence Immunoassay) by Huzhou Jierunxin Biotechnology Co., LTD — Class IVD General — IVDD — listed in EUDAMED

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-06979878281351	Class IVD General	Active

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Manufacturer

Manufacturer: Huzhou Jierunxin Biotechnology Co., LTD
EUDAMED SRN: CN-MF-000047637
Authorised Representative: RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Sources (1)

EUDAMED 9ea9f7e5-04ac-4398-8c2e-23516b5f416a 61 fields · synced Jul 21, 2026