CMT Health PTE., Ltd.

CMT Health PTE., Ltd. manufactures enteral and oral feeding syringes, including reusable and disposable models with ENFit adaptors and caps, low dead space syringes for tuberculin and insulin administration, safety syringes, disposable needles, and general-purpose disposable syringes with or without needles. These products are designed for specific clinical uses such as feeding, vaccination, and insulin delivery, and are based solely on the examples provided in the device data.

CMT Health PTE., Ltd. is based in the United States, as explicitly stated in the device data under the COUNTRY field and confirmed in the SUMMARY section of the provided device data. This location refers to the manufacturer’s headquarters or primary operational base, which is relevant for regulatory jurisdiction and device listing purposes.

CMT Health PTE., Ltd.'s devices are listed in the FDA 510(k) registry, as indicated in the LISTED IN field and reiterated in the SUMMARY. This means the company has submitted premarket notifications for its devices to demonstrate substantial equivalence to legally marketed predicates, which is a requirement for Class II devices seeking U.S. market access.

CMT Health PTE., Ltd.'s devices are classified as Class II medical devices, as specified in the DEVICE CLASSES field and confirmed in the SUMMARY. This classification indicates that these devices require special controls to ensure safety and effectiveness, such as performance standards, post-market surveillance, or specific labeling requirements, and are subject to FDA 510(k) clearance before marketing.