With Obelis Group’s support, TTK Healthcare Limited successfully completed EUDAMED verification for its Class III heart valve devices, strengthening MDR compliance and supporting its continued growth in the European market.
Success Stories
Bringing Premium Skincare to the EU and UK Markets with Confidence
ODACITÉ partnered with Obelis Group to achieve EU and UK compliance for its Nourishing Lip Serum SPF 40. With support for safety assessment, product notifications, and regulatory guidance, the brand successfully brought its product to market with confidence.
Successfully Managing Large-Scale EUDAMED Compliance
JIANGSU BONSS MEDICAL TECHNOLOGY CO., LTD. successfully completed large-scale EUDAMED verification for more than 1,100 medical devices with the support of Obelis Group, ensuring efficient EU compliance and smooth registration of Class Ir and Class Is devices.
Ensuring Seamless EU Market Continuity Through EUDAMED Expertise
Biobeat Technologies Ltd. successfully completed its EUDAMED verification and mandate update with the support of Obelis Group, ensuring uninterrupted access to the EU market through clear regulatory guidance and expert support.
Ensuring EU Compliance for High-Quality Cycling Components
Ritchey Design Inc. partnered with Obelis Group to ensure full EU compliance for its product portfolio under the GPSR. Through expert technical reviews and ongoing Authorized Representation, Ritchey reinforces its commitment to safety and excellence in the European cycling market.
Confident UK Market Access Through Expert Regulatory Support
Koru Pharma Co., Ltd. successfully entered the UK market with the expert regulatory support of Obelis Group. Through clear guidance on MHRA registration and UK-specific requirements, the process was smooth, efficient, and fully compliant.
Seamless UK Compliance for Fragrance Portfolio Expansion
SUPERZ Perfume Kft. partnered with Obelis Group to ensure full UK compliance for 29 fragrance products. With expert guidance from Obelis consultant Sofia Rocha, all products were successfully reviewed and notified, enabling smooth market entry while strengthening internal processes for future growth.
Confident EU Market Entry Through Expert IVDR Support
Athenese-Dx partnered with Obelis Group to navigate the EU IVDR process, achieving full compliance and successful EUDAMED registration for their biochemistry analyser, enabling confident entry into the EU market.
Clear Guidance for a Smooth EU Class A IVD Notification
With clear guidance from Obelis Group, Kogenebiotech Co., Ltd. achieved a smooth, confident, and fully compliant EU Class A IVD notification through transparent communication and precise guidance.
Building Confidence for UK Market Entry
Luxe Assist Global Inc. partnered with Obelis Group to streamline compliance, refine labelling, and confidently achieve a smooth, delay-free UK market entry for their microneedle derma roller.