China First! Perlove Medical’s Pld9600 Series Makes History As The First Domestic DRF To Obtain EU CE Certification

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Recently, Perlove Medical’s PLD9600 series dynamic flat panel DRF obtained the EU CE-MDR certification, marking the first MDR CE certificate for DRF in China.

quality management system regulation on medical devices

 Since May 2023, Perlove Medical has been preparing for CE certification, a process that lasted approximately 10 months. During this period, we not only completed documentation but also engaged in in-depth technical discussions with TÜV Rheinland, Germany, and promptly addressed audit findings. Compared to the conventional 15 to 18-month certification timeline, we efficiently completed the certification process, showcasing the professional capabilities of the Perlove Medical team.

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  The EU CE-MDR certification is a rigorous market access system implemented by the European Union for medical device products, covering various aspects such as safety, effectiveness, and compliance. This approval will aid Perlove Medical in further expanding into the EU market and enhancing the brand influence of its products globally.

2023 medical device ranking list
(The ranking data is sourced from YiBai Intelligence)

 As a prominent domestic medical equipment enterprise, Perlove Medical has long been dedicated to continuous technological innovation, particularly in the dynamic DR segment. In the 2023 Medical Equipment Procurement and Bidding Ranking, Perlove Medical clinched the top spot in the industry for market share in the dynamic/GI DR market segment, demonstrating our unwavering dedication to excellence in the field.

   Perlove is customer demand-oriented and has always demonstrated a strong commitment to society with the right and qualified product and service. As a high-tech company, Perlove firmly engages in self-research and technology innovation to make products close to clinical demands and continuously enhance medical technology. All come to help the improvement of global medical condition and reduce the medical cost.

  We eagerly anticipate the opportunity to collaborate with you to usher in a new era in the realm of medical imaging equipment!

  For inquiries regarding our Dynamic FPD Digital Radiography & Fluoroscopy System or CE certification, or for further information, please do not hesitate to contact us. We are dedicated to serving you!

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