Class IIa Medical Device

Class IIa Medical Device constitute medium-risk devices such as orthodontic wires, surgical gloves, lancets, etc. For Class IIa the declaration of conformity is backed up by notified body assessment post submission of technical documentation file. It holds a unique position within this classification system, embodying a delicate balance between innovation and patient safety.

Class IIa Medical Device encompass a wide range of medical technologies, often involving devices that come into contact with the body for diagnostic, therapeutic, or monitoring purposes. Some examples of Class IIa devices include:

1: Non-invasive Blood Pressure Monitors: Devices that measure a patient’s blood pressure without penetrating the skin fall under this category. These monitors are commonly used in clinics, hospitals, and home healthcare settings.

2: Infusion Pumps: Infusion pumps are used to deliver fluids, such as medications or nutrients, into a patient’s body in controlled amounts. They are vital in various medical treatments.

3: Contact Lenses: Non-corrective and corrective contact lenses for medical purposes fall under Class 2a. These lenses can have various applications, such as therapeutic or cosmetic use.

4: Diagnostic Ultrasound Devices: Ultrasound devices used for diagnostic imaging purposes, such as obstetric ultrasound, are classified as Class 2a. They are crucial tools in prenatal care and diagnostics.

5: Dental Filling Materials: Dental products like dental fillings and crowns that are intended to be placed within the oral cavity fall under this category.