Comprehensive sterility testing services for medical devices and consumables to verify absence of viable microorganisms. Testing includes bacterial and fungal analysis according to pharmacopeial standards.
Manufactured by
Dongguan City Yixin Sterilization Technology Service Co., Ltd
China
Yixin Sterilization Technology Service is a professional ethylene oxide (EO) sterilization service provider for medical devices, cosmetics, toys, and hygiene products. Located in Dongguan with convenient access to Guangzhou and Shenzhen, the company operates 2,000 sqm facilities with 6 and 20 cubic meter EO sterilizers capable of 50 cubic meters daily capacity. Operations comply with ISO11135 international standards, with quality management systems established per ISO13485 requirements.
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CleanControlling Medical GmbH & Co. KG · Germany
Accredited laboratory testing services for biological contamination analysis of medical devices. Comprehensive assessment of bioburden, endotoxins, and sterility according to relevant standards.
Changzhou Emanmed Biotechnology Co., Ltd · China
Laboratory sterility testing service for medical devices following final sterilization. Validates absence of viable microorganisms to confirm sterile assurance level requirements for medical device manufacturers.
CleanControlling Medical GmbH & Co. KG · Germany
Chemical analysis and testing services for medical devices to identify residual contaminants, extractables, and chemical composition. Ensures compliance with regulatory requirements for patient safety.
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