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What is an example of a Class I medical device?

UDI Policy Regarding Certain Class I and Unclassified Devices 1,2

Category of device Category of device Category of device Additional information pertaining to dir ...
Class I and unclassified devices Non-sterile Manufactured and labeled prior to 9/24/2 ... Unique Device Identification: Policy Reg ...
Class II devices other than implantable ... Non-sterile Manufactured and labeled prior to 09/24/ ... Unique Device Identification: Policy Reg ...
Class II devices other than implantable ... Sterile Manufactured and labeled prior to 09/24/ ... Alternative UDI-A170001
LS/LS devices Non-sterile Manufactured and labeled prior to 09/24/ ... Unique Device Identification: Policy Reg ...

Nov 16 2021

What are Class II medical devices?

  • Class II Medical Device : General Controls with Special Controls. 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, and acupuncture needles.

What is a Class II medical device?

  • Class II medical devices are those for which general controls alone are insufficient to assure safety and effectiveness, and additional existing methods are available to provide such assurances. Therefore, Class II devices are also subject to special controls in addition to the general controls of Class I devices.

What are examples of Class III medical devices?

  • Class III – These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Examples of Class III devices include implantable pacemakers and breast implants. 10% of medical devices fall under this category.

What is an example of a Class I medical device?What is an example of a Class I medical device?

Class I devices are considered to be at the lowest level of risk of all medical devices and are therefore required to comply with the lowest level of regulatory control. Examples of Class I devices include: elastic bandages, dental floss and enemas.

image-What is an example of a Class I medical device?
image-What is an example of a Class I medical device?
Related

What are Class II medical devices?What are Class II medical devices?

Class II Medical Device : General Controls with Special Controls. 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, and acupuncture needles.

Related

What is a Class II medical device?What is a Class II medical device?

Class II medical devices are those for which general controls alone are insufficient to assure safety and effectiveness, and additional existing methods are available to provide such assurances. Therefore, Class II devices are also subject to special controls in addition to the general controls of Class I devices.

Related

What are examples of Class III medical devices?What are examples of Class III medical devices?

Class III – These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Examples of Class III devices include implantable pacemakers and breast implants. 10% of medical devices fall under this category.

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