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.
Success Stories
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.
Strategic Compliance for a New Generation of Wellness Products
Kind Patches Ltd. partnered with Obelis Group to build a clear, future-proof compliance strategy for launching nutrient-delivery wellness patches in the EU and UK. Through in-depth regulatory research, step-by-step consultancy, and EU/UK GPSR compliance reviews, Obelis helped transform complex requirements into a structured pathway for confident market entry and long-term growth.
EU Market Entry Success Story: RED Directive Compliance in 7 Days with Obelis VIP
Discover how Boundless Devices Inc., a U.S.-based technology company, successfully entered the EU market in just 7 days. With Obelis Group’s VIP service and EAR support, the company achieved fast and seamless compliance under the Radio Equipment Directive (RED), transforming regulatory complexity into a confident and efficient EU market launch.
Navigating UK Medical Device Registration
KORAVIE LIMITED, a UK-based start-up, partnered with Obelis Group to navigate the complexities of UK medical device registration. With expert guidance and hands-on support, they transformed regulatory uncertainty into a successful market launch—laying the groundwork for EU expansion.
From EMC to GPSR: A Tailored Compliance Journey into the EU and the UK
HELLO CHAKRA LLC, a U.S.-based wellness brand, set out to expand into the EU and UK with a new product line under the General Product Safety Regulation (GPSR). With expert guidance from Obelis Group they successfully navigated product classification, documentation, and compliance—ensuring a confident and well-prepared market entry.
TrailHeads Enters EU Market with Obelis Compliance Support
TrailHeads, a U.S. outdoor brand, partnered with Obelis Group to navigate GPSR compliance and launch successfully in the EU, overcoming Amazon-related challenges and accelerating their market entry.
Medical Devices (Pvt) Ltd.: Seamless Market Access, Powered by Partnership
Medical Devices (Pvt) Ltd. partnered with Obelis Group to overcome regulatory challenges and successfully launch in the EU, UK, and Swiss markets with expert support and streamlined compliance.