Class 2 Medical Devices List. 43% of medical devices fall under this category. As per rule 2 ,medical device intended for channeling or storing for eventual administration except with the use of blood and connected to an active device is class 1 medical device.
Blood pressure or blood sugar monitoring machines. Class i medical devices do not require a medical device licence and are monitored by the health products and food branch inspectorate (compliance and.
40 Grand Dive Portable Hyperbaric Oxygen Chamber Summit
Class ii medical devices are held to a higher level of assurance than class i medical devices in that they will perform as indicated and will not cause injury or harm to patient or user. Class ii medical devices are those devices that have a moderate to high risk to the patient and/or user.