Shenzhen Teslong Technology Co., Ltd

Shenzhen Teslong Technology Co., Ltd specializes in direct-view otoscopes, which are handheld devices used primarily for examining the ear canal and tympanic membrane in clinical settings. These devices are designed for basic otological assessments and are commonly used in retail pharmacies, like Walgreens, as well as primary care offices.

The company is based in the United States, where it operates as a manufacturer of its otoscope products. Its location ensures compliance with U.S. regulatory standards applicable to the devices it produces.

Shenzhen Teslong Technology Co., Ltd’s otoscopes are classified as FDA Class I medical devices. This classification applies to low-risk diagnostic tools that pose minimal risk to patients, requiring less stringent regulatory oversight compared to higher-risk devices.

Yes, the company’s otoscopes are listed in the FDA’s Unique Device Identification (UDI) database. This database helps track and identify medical devices in the U.S. market, ensuring transparency and traceability for regulatory and clinical purposes.