From your post it is not clear to me what your device does. But the rules that apply, as far as I can see, are:
2. Invasive devices
2.1. Rule 5
All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device:
- are in Class I if they are intended for transient use,
- are in Cla!s lla if they are intended for short-term use, except if they are used in the oral cavity as far as the pharvnx, in an car canal up to the car drum or in a nasal cavity, in which case they are in Class I,
- are in Class IIb if they are intended for long-term use, except if they are used in the oral cavity as far as the phar).nx, in an ear canal up to the car drum or in a nasal caviry and are not liable to be absorbed by the mucous membrane, in which case they are in Class IIa.
All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to an active medical device in Class lla or a higher class, are in Class IIa.
2.2. Rule 6
All surgically invasive devices intended for transient use are in Class lIa unless they arc:
- intended specifically to diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,
- reusable surgical instruments, in which case they are in Class I,
- intended to supply energy in the form of ionizing radiation in which case they are in Class llb,
- intended to have a biological effect or to he wholly or mainly absorbed in which case they are in Class IIb,
- intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which they are in Class lIb.
So, I'm guessing, yours would be a Class IIa