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.
Testimonials
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.