May.2024 24
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MacroLux receives CE-MDR Certificate for Single-Use Digital Flexible Ureteroscope (no. 3)
Introduction
Proud Announcement: Our Single-Use Digital Flexible Ureteroscope Receives CE Certification for EU Market Access
Details


We are thrilled to announce that following our successful NMPA and FDA approvals, today marks another significant milestone for our company. Our CoralView® Single-Use Digital Flexible Ureteroscope has obtained the CE certification, compliant with the European Union's new Medical Device Regulation (REGULATION (EU) 2017/745, referred to as MDR), issued by the EU Notified Body - TÜV SÜD Product Service GmbH. This certification grants us authorization to distribute our product in the EU region.

 

The CE certification is a mandatory requirement for market access in the European Union. The EU's new Medical Device Regulation (MDR) aims to establish a stricter and modern regulatory framework, ensuring better protection of public and patient health. It imposes more rigorous requirements on medical device manufacturers in terms of safety, efficacy, and quality management throughout the product's lifecycle.

 

At MacroLux Medical, we prioritize compliance with legal and regulatory requirements in various global regions. We remain committed to our company's vision, mission, and quality policy, consistently delivering safe, effective, and innovative medical devices to our valued customers worldwide.