Haho Medi

Haho Medi specializes in automated and semi-automated tissue processors intended for in vitro diagnostic (IVD) applications. Their primary focus is on devices designed to prepare and process tissue samples, such as the mixsoon Derma Booster PRO, which is tailored for skin tissue in laboratory environments.

Haho Medi is based in the United States, which means its devices fall under the jurisdiction of the FDA. Since the company’s products are classified as Class I medical devices, they are subject to FDA’s regulatory framework, including requirements for listing in the UDI database to ensure traceability and compliance.

Yes, Haho Medi’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical because it provides transparent identification of medical devices, enabling better tracking, recall management, and compliance verification by healthcare providers, regulators, and other stakeholders.

Haho Medi’s devices are classified under FDA’s Class I category. This classification typically means the devices pose minimal risk and are subject to general controls, such as good manufacturing practices (GMP) and labeling requirements, rather than stringent pre-market approval processes. However, compliance with UDI listing and other applicable regulations remains essential.