Cofoe Medical Technology (301087.SZ): The Real Ear Test Instrument has obtained a medical device registration certificate.

Cofoe Medical Technology (301087.SZ) announced that their product, the Real Ear Test Instrument, recently obtained the "Medical Device Registration Certificate" issued by the Hunan Provincial Food and Drug Administration. The Real Ear Test Instrument is a professional device used to assess the function of the human auditory system, widely applied in the fields of audiology, hearing aid fitting, and auditory rehabilitation. The company's Healthy Hearing Aid Fitting Center extensively utilizes this equipment. The Real Ear Test Instrument that obtained the medical device registration certificate this time integrates low cost, multiple modules, and high precision. With the production of this equipment, it will help in reducing the investment costs for setting up new hearing aid fitting centers. By expanding the coverage of existing fitting centers, the professional level of the stores will be further enhanced. The above-mentioned Real Ear Test Instrument is the first domestically produced product with complete independent intellectual property rights to obtain a Class II medical device registration certificate, filling the technical gap in domestically produced Real Ear Test Instruments. This product breaks through core technological barriers, achieves domestic substitution, and significantly reduces the procurement costs for clinical and consumer end devices. This product effectively complements the company's hearing equipment product matrix, enhancing the company's comprehensive competitiveness in the medical device field, laying the foundation for future market share growth.