News & Events

Company News

  • 4L Health Passed TÜV Re-Certification Audit on ISO13485 & CE
  • 24 July 2015

  •          On Jul 24 2015, a re-certification audit team led by Mr. Wang from TÜV SÜD Group conducted a site audit to 4L Health Co., Ltd.
             The re-certification audit includes ISO 13485:2003 quality management system and 93/42/EEC certificates. 4L Health successfully passed the audit and achieved good comments from TÜV SÜD experts.
             The medical devices are related to life & health. To ensure product quality, all colleagues paid great efforts to maintain the R&D and production quality system to promote product safety and effectiveness. Hard work results in great harvest. In 2012, 4L Health became the first NPWT system manufacturer which achieved NPWT system CE certificate and EU R&D production quality management system certificate. In 2013, 4L Health became the first NPWT manufacturer which achieved approval (FDA 510k) of entering the US market and the first NPWT manufacturer which passed US FDA site audit.
             With the 20 years historical deposition of R&D and production in medical devices together with 30 years in electronics products, we are devoted to developing high cost-effective NPWT systems.

             4L: FOR LIFE, FOR LOVE.

Copyright © 4L Health Co., Ltd. & Foryou Medical Electronics Co., Ltd. All Rights Reserved.