Foryou NPWT: Negative Pressure Wound Therapy by 4L Health

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Company News

  • 4L Health Passed TÜV Re-Certification Audit on CE & ISO13485
  • 22 March 2017

  •          On March 22 2017, a re-certification audit team led by Ms. LIU Chunying from TÜV SÜD Group conducted a site audit to 4L Health Co., Ltd.
             The re-certification audit includes 93/42/EEC certificates and the ISO 13485:2003 quality management system. 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 and only NPWT manufacturer in China which achieved approval (FDA 510k) of entering the US market and the first NPWT manufacturer, as well as the first and only NPWT manufacturer in China which passed US FDA site audit. In 2016, 4L Health became the first and only NPWT manufacturer in China which passed the US FDA site re-audit.
             With the 22 years historical deposition of R&D and production in medical devices together with 32 years in electronics products, we are devoted to developing high cost-effective NPWT systems.

             FORYOU NPWT, FOR YOUR NPWT.
             4L: FOR LIFE, FOR LOVE.



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