SHINA MED CORPORATION

Shina Med Corporation specializes in diabetes management devices, specifically insulin syringes and autoinjector needles. Their product line includes pre-filled insulin syringes in various volumes (0.3cc, 0.5cc, and 1.0cc) with different needle gauges (ranging from 28G to 32G) for subcutaneous insulin delivery. They also produce needles designed to work with insulin pens for autoinjector devices.

Shina Med Corporation is based in the United States. Their devices are designed and intended for use within the U.S. regulatory environment, ensuring compliance with applicable medical device standards and requirements.

Shina Med Corporation’s devices are classified as Class II by the FDA. This classification applies to devices that generally pose moderate risk and require special controls to ensure safety and effectiveness, such as insulin syringes and needles, which require validation of performance and labeling requirements.

Shina Med Corporation’s devices are listed in the FDA’s 510(k) database and the FDA’s Unique Device Identifier (UDI) system. These registries track medical devices that have undergone the FDA’s premarket notification process (510(k)) and require a UDI for traceability and identification.

The FDA categorizes insulin syringes and needles as Class II because they are considered to pose moderate risk to patients. While these devices are relatively simple in design, their use involves direct contact with the body and requires precise functionality to ensure safe and effective administration of insulin. Class II classification mandates special controls, such as performance testing, labeling standards, and post-market surveillance, to mitigate risks like improper dosing or needle breakage.