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.
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.
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.
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.
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.
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.
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.
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.
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.
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.