ENVIZION MEDICAL LTD

Envizion Medical Ltd specializes in nasogastric feeding tubes, which are used for delivering enteral nutrition directly into the stomach or intestines. Their portfolio includes tubes with stylets for easier insertion, as well as versions featuring the standardized ENFit® connector to enhance safety during attachment. The company also produces complementary accessories like sensor clips with adhesive patches, which support monitoring systems for enteral feeding.

Envizion Medical Ltd is based in the United States. Its devices are authorised through FDA regulatory pathways, specifically as Class II medical devices. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as nasogastric feeding tubes.

Envizion Medical Ltd’s devices are listed in the FDA’s 510(k) database, which tracks premarket submissions for devices deemed substantially equivalent to legally marketed predicates. Additionally, their products appear in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with identification requirements for medical devices in the U.S.

Envizion Medical Ltd’s nasogastric feeding tubes are classified as Class II devices under FDA regulations. This classification is based on the level of risk associated with the device. Class II devices require special controls in addition to general controls to ensure their safety and performance, such as performance standards, post-market surveillance, or labeling requirements.