Class II Certification
AQUA DETOX™ Medical Device Class II Certification
Regulatory authorities recognize different classes of medical devices based on their design complexity, their use characteristics, and their potential for harm if misused. Each country or region defines these categories in different ways.
Class II Medical Devices, such as Aqua Detox, are those for which general controls alone are insufficient to assure safety and effectiveness, and additional existing methods are available to assure safety and effectiveness. Class II medical devices are a subject to special controls in addition to the general controls of Class I medical devices. Special controls may include special labeling requirements, mandatory performance standards, and postmarket surveillance.
Medical Devices in Class II are held to a higher level of assurance than Class I devices in that they will perform as indicated and will not cause injury or harm to the patient or the device user. Devices in this class are typically non-invasive and include x-ray machines, PACS, powered wheelchairs, infusion pumps, surgical drapes, surgical needles and suture material,acupuncture needles.
The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) regulates medical devices under European legislation. Medical devices must not be mistaken with medicinal products. In the European Union (EU), all medical devices must be identified with the CE mark.
CLICK HERE for information on the Medical Device Class II Certification Process.