SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.

Shenzhen Hainwise Medical Technology Co., Ltd. specializes in producing guidewires for medical procedures. Their devices include angiographic guidewires, primarily used in vascular applications, as well as hydrophilic guidewires designed specifically for urinary tract interventions. These guidewires assist in navigating catheters or other instruments through blood vessels or the urinary system.

The company is headquartered in Shenzhen, China. This location serves as the primary base for its operations, though the company may have additional facilities or partnerships elsewhere for manufacturing, distribution, or research.

The company’s devices are listed in the EUDAMED registry, which is the European database for medical devices. This registry tracks devices that have undergone the necessary conformity assessment procedures under EU regulations, ensuring transparency and traceability for authorized products.

The company’s guidewires fall under Class IIa classification in the EU. This classification is assigned based on risk assessment criteria—Class IIa devices pose moderate risks and require specific conformity assessment procedures, such as involvement of a Notified Body, to ensure safety and performance before authorization.