Regulatory & Compliance

Zensorium’s commitment is to offer quality medical devices that satisfy applicable statutory and regulatory requirements.

ACT by Zensorium

ISO 13485:2016 Medical Devices – Quality Management Systems – Requirements for regulatory purposes
Scope: Design & Development, Production, Servicing and Distribution of In Vitro Diagnostic System (Reagents and Instruments) used for quantitative determination of albumin, creatine and albumin/creatine ratio (UACR) in human urine

Nitto-DenkoQ5-002160-0005-Rev.-00EN-ISO-13485-certificate

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