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.
Testimonials
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.
Accelerating Global Expansion Through Expert EU Regulatory Support
Obelis Group supported RF Medical Co., Ltd. with the efficient issuance of EU Free Sales Certificates, enabling compliant and timely medical device registrations in Jordan and Vietnam to support global market expansion.
Seamless MHRA Updates Enabling Continued Market Access for Dental Devices
Obelis Group supported RNDENT, a manufacturer of Class I dental medical devices, with a seamless MHRA registration update during account renewal, ensuring uninterrupted access to the UK market through efficient and compliant regulatory support.