Creatine Kinase MB Isoenzyme Chemiluminescence Immunoassay Kit

EUDAMED

Class IVD General (EU MDR)

Ref 100tests/kitModel Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 100tests/kitModel Reagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 100tests/kit

by Nanjing RealMind Biotech Co., Ltd.

Identity

Device Name: Creatine Kinase MB Isoenzyme Chemiluminescence Immunoassay Kit EUDAMED
Model / Reference: Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 100tests/kit EUDAMED
100tests/kit EUDAMED
Reagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 100tests/kit EUDAMED

Identifiers

Primary DI / UDI-DI: 06972719604791 EUDAMED
06972719601806 EUDAMED
Basic UDI-DI: B-06972719604791 EUDAMED
B-06972719601806 EUDAMED
EMDN Code: W01021311 CREATINE KINASE - MB MASS (IC) EUDAMED

Classification

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

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Creatine Kinase MB Isoenzyme Chemiluminescence Immunoassay Kit by Nanjing RealMind Biotech 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-06972719604791	Class IVD General	Active

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Manufacturer

Manufacturer: Nanjing RealMind Biotech Co., Ltd.
EUDAMED SRN: CN-MF-000024838
Authorised Representative: Lotus NL B.V. NL-AR-000000121

Sources (2)

EUDAMED 779f1352-ad6f-4837-8220-e40b88ebd359 61 fields · synced Oct 7, 2026
EUDAMED 08016ae8-f7e6-4e12-bfba-ad746e20c4be 61 fields · synced May 19, 2026