Jms Co., Ltd.

Jms Co., Ltd. specializes in single-use medical devices, focusing on general-purpose syringes and specialized variants. Their portfolio includes large-volume syringes (like a 100mL center-nozzle syringe without a needle), vented intravenous sets, and apheresis needles. They also produce fistula needle sets in various designs (e.g., accordion or wing-eater types) and combinations of needles with syringes, particularly for vascular access procedures. These devices cater to clinical needs like fluid administration, apheresis, and fistula maintenance.

Jms Co., Ltd. is based in the United States, which means its devices must comply with U.S. medical device regulations. Since their products fall under Class II classification, they are subject to stricter controls than Class I devices but not as rigorous as Class III. The company’s location ensures alignment with FDA requirements, including mandatory registration in the FDA’s 510(k) and UDI (Unique Device Identification) systems to track and authorize these devices for market distribution.

Jms Co., Ltd.’s devices are listed in the FDA’s 510(k) and UDI registries. The 510(k) process demonstrates that a device is substantially equivalent to a legally marketed predicate, while UDI ensures traceability and transparency in the supply chain. These registries are critical for tracking device safety, compliance, and recall management, as well as for healthcare providers and regulators to verify authorized products before use.

Jms Co., Ltd.’s devices are classified as Class II under U.S. regulations, which applies to products posing moderate risk to users. This classification requires manufacturers to comply with special controls—such as performance standards, labeling requirements, or post-market surveillance—to ensure safety and effectiveness. While Class II devices undergo more scrutiny than Class I, they do not require the rigorous premarket approval process of Class III devices, which are typically higher-risk.