Pinemedics Obtains CE MDR Certification for Seven Endoscopic Procedure Devices

Expansion into Major European Markets... Plans for Entry into the Middle East and Africa

Pinemedics announced on June 11 that it has obtained CE MDR (European Medical Device Regulation) certification for seven types of endoscopic procedure devices.

FineMedics company logo image. FineMedics

With this certification, the company has secured a foundation to sell these products in 30 countries of the European Economic Area (EEA), including all 27 European Union (EU) member states. Based on this, Pinemedics plans to further expand into major European markets such as Germany, France, and Italy, and also pursue product registrations in the Middle East and Africa.

The certified products include seven items: Clearcut Knife, Cleartip, Cleargrasp Snare, Clear Hemograsper, Clearbite Biopsy Forceps, Clearcap, and Clearjet Injection Catheter. All are next-generation models developed after the previous CE MDD certification.

These devices are used in endoscopic procedures for lesion resection, tissue sampling, hemostasis, and drug injection. Pinemedics explained that this certification allows the company to expand its portfolio of overseas supply products to include next-generation models. The CE MDR is a European regulation that strengthens requirements for safety, clinical evidence, and quality management systems compared to the previous Medical Devices Directive (MDD).

Pinemedics has also already obtained major medical device certifications from the U.S. FDA, Japan's Ministry of Health, Labour and Welfare (MHLW), and Brazil's National Health Surveillance Agency (ANVISA). The company plans to use the MDR certification as an opportunity to expand its ODM business tailored to the demands of each country.

The company is currently discussing strategic partnerships with German and British medical device companies for the second half of the year. In addition, Pinemedics intends to expand its ODM business based on MDR-certified products by utilizing the global sales network of SonoScape, a Chinese endoscopy equipment company it has been collaborating with since 2024.

Seongu Jeon, CEO of Pinemedics, stated, "With this MDR certification, we are able to expand the range of products we can supply to overseas markets," adding, "We plan to strengthen existing partnerships and also work to secure new sales channels."

This content was produced with the assistance of AI translation services.