Global Compliance & Consumer Confidence

Calmedix Manufacturing Pte Ltd | Calmedix Australia Pty Ltd

Calmedix, an extension of Caltekgroup is a company manufacturing disposable face and medical masks operating in a stringent, Class Approved NEBB certified clean room facility.

Our products are manufactured in Singapore in compliance with ISO 13485:2016.
The technical standards, ASTM F2100:19 and EN 14683:2019 is a key compliance requirement to ensure fortified quality and superior-grade levels in the masks that are manufactured. At Calmedix, our masks are manufactured with validated processes, specific to these key standards to ensure global compliance and consumer confidence.

Calmedix’s team, equipped with years of metrological, scientific, and environmental knowledge and experience, delivers a robust edge on the operational and environmental requirements. Our cleanroom facility is made under conditions to reduce particulate contamination and control other environmental parameters such as temperature, humidity, and pressure.

Protocols with design considerations consisting of separated airlocks, supplying airflow in sufficient volume (HVAC System), filtration system, to procedural considerations for gowning, entry and exits. Operators are trained to uphold contamination control theory and are thus qualified to operate critical controlled environments before actual operations.