LAGIS receives CE(MDR), expanding its product coverage under the Medical Device Regulation 2017/745
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11/09/2023

Lagis Enterprise Co., Ltd.

LAGIS receives CE(MDR), expanding its product coverage under the Medical Device Regulation 2017/745

Our surgical devices, LAGIS Trocar and kits (Single-Use), Minimally Invasive Surgery Surgical Instruments (Single-Use), Endotherapy Devices (Other Accessories), Irrigators, Gynaecological Devices (Other), Veress Needles, Mono- and Bipolar-Surgical Instruments (Single-Use) meet all legal requirements and have been certified according to Regulation (EU) 2017/745 (MDR) since May 17, 2023 (Current Issue Date: May 17, 2023; First Issue Date: May 31, 2022) . The certification process was diligently and proficiently conducted by BSI The Netherlands (2797), ensuring a comprehensive and meticulous assessment.

By obtaining MDR certification for our surgical devices, we actively enhance public health and patient safety. Detailed information regarding the certificate, including a comprehensive overview of the covered products, historical records, and associated conditions, can be accessed as follows:

Exhibitor Data Sheet