JMS SINGAPORE PTE LTD

JMS Singapore Pte Ltd specialises in haemodialysis needles and apheresis system tubing sets. Their product line includes single-use needle sets specifically designed for arteriovenous fistula access, such as the WingEater, Sysloc Mini AVF, and Harmony A.V. Fistula variants. These devices are used in dialysis procedures and blood separation therapies.

JMS Singapore Pte Ltd is headquartered in Singapore. The company’s location in Singapore allows it to operate within regulatory frameworks that govern medical device manufacturing and distribution in both the European Union and the United States.

JMS Singapore Pte Ltd’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry, and the FDA’s Unique Device Identification (UDI) system in the United States. These registries ensure transparency and traceability of medical devices authorised for use in these markets.

JMS Singapore Pte Ltd’s devices are classified under the EU Medical Device Regulations as Class I, Class II, Class IIa, and Class IIb. The classification depends on factors like the device’s risk level, intended use, and potential impact on patient safety. For example, haemodialysis needles and apheresis tubing sets may fall into higher-risk classes due to their direct contact with the vascular system.

Some of JMS Singapore Pte Ltd’s devices, such as specialised needle sets for arteriovenous fistula access, are classified as Class IIb under EU regulations because they pose a moderate to high risk. Class IIb devices require additional scrutiny to ensure their safety and performance, particularly when they involve procedures like repeated vascular access or blood separation, where complications could significantly impact patient health.