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Date: November 11 (Mon) - November 14 (Thu), 2024Location: Düsseldorf, GermanyBooth Number: 11H59LowTem will showcase a range of innovative sterilization solutions at this year’s exhibition. Recently, LowTem received FDA 510(k) approval, paving the way for entry into the U.S. market, and has also passed CE MDR certification, strengthening its presence in the global market.

2024-10-24

LOWTEM sterilization system has received 510(k) clearance from the United State Food and Drug Administration (FDA). This recognition officially confirms the safety and the performance of LOWTEM sterilizer in the global market, establishing itself as a reliable product. The FDA 510(k) clearance indicates that the LOWTEM sterilization system is substantially equivalent to existing similar sterilizers, ensuring the healthcare professionals and patients can trust and utilize a high-quality sterilizer.

2024-09-30

Here’s the news regarding the FDA (U.S. Food and Drug Administration) reclassification of VHP (Vaporized Hydrogen Peroxide) sterilization as a Category A technology on May 28, 2024 (reclassification date: January 8, 2024).Vaporized hydrogen peroxide sterilization has been widely used since the early 2000s, with demand continually increasing. In 2022, the standards for vaporized hydrogen peroxide sterilization were developed, leading to the publication of ISO 22441. This development is expected to significantly enhance the global standing of vaporized hydrogen peroxide sterilization.LOWTEM is committed to becoming a company that meets global demands with proven efficacy and safety.For more detailed information, please click the link below.Regulatory developments in industrial VHP sterilisation - Medical Plastics News

2024-09-30

Here is the news regarding the EPA (Environmental Protection Agency) announcement on March 14, 2024, of new EtO sterilization emission regulation.This regulation strengthen the emission standard for hazardous emission related to EtO sterilization, requiring continuous emissions monitoring and reporting. The EPA aims to reduce emissions from commercial sterilizers by over 90%. At the same time, the FDA (U.S. Food and Drug Administration) is developing alternative sterilization methods and emission reduction strategies, working to mitigate health risks to workers and communities.In response, LOWTEM is committed to continuously monitoring evolving environmental regulations and promptly adapting to any regulation changes. For more detailed information, please refer to the link below.https://www.medicalplasticsnews.com/medical-plastics-resources/sponsored-content/regulatory-developments-in-industrial-vhp-sterilisation/

2024-09-30

We invite you to FIME 2024 in Miami, the largest expo in USA.A. FIME 2024B. June 19 (Wed) - June 21 (Fri), 2024 (3 days)C. Miami Convention Center, USAD. Booth No: L 56 (Korea Pavilion)

2024-06-03