CALMEDIX MANUFACTURING PTE LTD Logo - medical devices

CALMEDIX MANUFACTURING PTE LTD

medical devices
China's Best One-Stop Medical Equipment Provider
About

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.

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Keywords
medical equipment manufacturingiso 13485:2016healthcaremedical equipment and supplies manufacturingfortified quality masksdisposable masksastm standardsair filtrationnebb certifiedmetrological expertiseenvironmental control protocolscontrolled environment manufacturingvalidated manufacturing processesmedical devices & life scienceshvac systemenvironmental controlmedical masksdisposable medical masksscientific expertiseb2bgowning protocolsfortified mask qualityclass approved clean roomsupply chain managementglobal compliancemask standardsmedical device manufacturingen standardsastm f2100:19disposable face masks
Company Information
  • Employees0
Location

23 Tagore Ln, Singapore, Singapore, 787601

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