Bangalore, India-based Healthium Medtech a global company focused on products used in surgical, post-surgical and chronic care, received the new EU Certification under the European Union’s Medical Device Regulation. (EU MDR)
The EU MDR requires stricter compliance, increased vigilance, robust complaint handling, regular customer and product feedback procedures, trend reporting requirements, along with periodic safety update reports.
In addition, the UDI ID will now be required on all devices to enhance traceability across the supply chain. A unique device identifier (UDI) is a unique numeric or alphanumeric code established by the FDA to adequately identify medical devices sold in the United States, from manufacturing through distribution to patient use.
Healthium currently operates eight integrated and scaled manufacturing facilities several of which have global accreditation and approvals such as US FDA, TGA, CDSCO, CE under MDD and now CE under EU MDR, among others.
Last updated: December 26th, 2025
