Taiwan-based medical device brand demonstrates regulatory excellence and commitment to patient safety.

(Taipei, Taiwan — December 19, 2025) Carilex Inc. (TWSE: 7726) announced that its Negative Pressure Wound Therapy (NPWT) product series has successfully obtained certification under the EU Medical Device Regulation (MDR). The certification was issued by DNV, an EU-designated Notified Body, confirming compliance with MDR requirements for Class IIb medical devices. Carilex is currently the only Taiwan-based brand to have achieved MDR certification for NPWT products.

Following the MDR certification of its Therapeutic Support Surface (TSS) products in early 2023, Carilex has now secured MDR approval for both of its core product lines, marking a major regulatory milestone. This achievement underscores the company’s strong capabilities in quality management, clinical validation, and regulatory compliance, and reflects its readiness to meet the stringent standards of the European medical device market.

The EU Medical Device Regulation (MDR), which replaces the former Medical Device Directive (MDD), sets the highest standards for medical devices in Europe, with stricter requirements for clinical evidence, documentation, post-market surveillance, and quality systems. By securing MDR certification for both its NPWT and TSS product lines ahead of the full implementation, Carilex demonstrates the strength of its regulatory and quality systems, reflecting its commitment to safe, reliable, and clinically validated devices that support healthcare professionals and enhance patient care.

As a Taiwan-based medical device brand, Carilex remains committed to Taiwan-designed, Made-in-Taiwan products that meet the highest standards of quality and reliability for healthcare providers worldwide.