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• The 1st in China! Foryou NPWT entire product line for the EU market has obtained MDR certification
• 02 July 2024
• 
           Great news! On July 2nd, 2024, 4L Health's entire Foryou NPWT product line for the EU market, including NPWT Dressing Kits and NPWT Pumps, has obtained the MDR (Medical Device Regulation) certification, which is the 1st MDR certification of NPWT Dressing Kit and NPWT Pump system in China!
  
           With the 1st EU MDR CE of NPWT Dressing Kits and the 1st EU MDR CE of NPWT Pumps and achieved in China, 4L Health's Foryou NPWT entire product line not only comply with the latest EU medical device regulations but also can serve the European and global healthcare markets even better.
           And 4L Health also achieved the 1st CE & ISO13485 Certificates of NPWT system in China, and obtained the 1st US FDA 510(k) clearance and the 1st US FDA site audit pass of NPWT device in China.
  
           "Directive" becomes "Regulation": MDR carries more weight
           The MDR, which was introduced by the EU in May 2017, is the latest medical device regulation, replacing the previous Medical Device Directive (MDD). Compared to MDD, the new MDR has stricter certification requirements, stronger regulatory oversight, and higher standards for products.
           The primary aim of MDR is to enhance the safety and effectiveness of medical devices and ensure consistency across the EU market. It encompasses requirements from design and production through post-market surveillance.
           Foryou NPWT's successful acquisition of the certification demonstrates that 4L Health's products meet the EU’s stringent standards for quality and safety, fully attesting to the outstanding technological innovation and quality management capabilities of 4L Health Co., Ltd. & Foryou Medical Electronics Co., Ltd.
           Gaining this MDR certification will open up more opportunities and expand our market share internationally. It also solidifies Foryou NPWT’s brand presence globally in the medical device sector, driving us towards new heights in our future development. We remain committed to developing innovative products and providing superior NPWT solutions to contribute to global healthcare.
           4L Health Co., Ltd. & Foryou Medical Electronics Co., Ltd. were transformed from the Medical Electronics Business of Foryou Group, which is one of the leading conglomerates engaged in R&D and manufacturing of electronics products in China.
  
           Foryou NPWT, FOR YOUR NPWT.
           4L: FOR LIFE, FOR LOVE.