News & Events

Company News

  • 4L Health Passed SGS Re-Certification Audit on ISO13485 & CE
  • 04 Dec. 2015

  •          On Dec. 3 and 4, 2015, a three-man re-certification audit team led by Mr. Ge from SGS-CSTC Standards Technical Services Co., Ltd. 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. Onsite check covers both the Dongjiang Science Park Factory and Foryou Industial Park Factory.
             After two days' audit, 4L Health successfully passed the inspection and achieved good comments from SGS experts.

             The medical devices are related to life & health. To ensure product quality, all colleagues paid great effort to maintain the R&D and production quality system to promote product safety and effectiveness. Hard work results in great harvest. In 2012, the Company became the first NPWT system manufacturer which achieved NPWT system CE certificate and EU R&D production quality management system certificate. In 2013, the Company 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 19 years of R&D and production experience in medical devices together with 29 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.