HHAO MEDI Achieves Major Regulatory Milestone: 11 Device Models Receive UDI-DI Approval in Europe.
Hongkong, China – HHAO MEDI, a professional manufacturer specializing in MRI-compatible medical devices, has announced a significant regulatory achievement. The company has successfully obtained Unique Device Identification – Device Identifiers (UDI-DI) for 11 of its product models across European countries. This approval marks a key step in the company's compliance with the stringent European Medical Device Regulation (MDR) 2017/745.
Strengthening European Market Presence
The UDI-DI system is a cornerstone of the EU's regulatory framework for medical devices, designed to enhance the traceability and transparency of medical devices throughout their lifecycle. By securing these identifiers, HHAO MEDI ensures that its products are fully aligned with the European database, EUDAMED, which facilitates better post-market surveillance and patient safety.
HHAO MEDI, operating under the brand Hongkong Medi with its manufacturing base in Hongkong, Guangxi, has been developing and producing medical devices since 2009. The company's core expertise lies in developing MRI Conditional devices compatible up to 3.0T and 7.0T. With a CE-certified quality management system and a history of exporting to over 60 countries, this latest regulatory compliance reinforces the company's commitment to quality and international standards.
Commitment to Quality and Innovation
HHAO MEDI has maintained a representative presence in Europe, including sales representatives in Italy and the UK, and has been successfully registered with local health authorities in 8 Asian countries. The company’s products, including MRI-compatible trolleys and transport stretchers, already carry the CE mark under the MDR, and this latest UDI-DI approval is an extension of their ongoing efforts to meet the highest regulatory standards.
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