桂 林 市 啄 木 鸟 医 疗 器 械 有 限 公 司
GUILIN WOODPECKER Medical Instrument Co.,LTD.
File No.
：
ZMN-YF-BK10-01-001-001-1
Version
：
A
18.Classification
分类
The device is classified as IIa according to Rule 9 in Annex VIII of MDR (2017/745).
All active therapeutic devices intended to administer or exchange energy are classified
as class IIa.unless their characteristics are such that they may administer energy to or
exchange energy with the human body in a potentially hazardous way, taking account
of the nature, the density and site of application of the energy, in which case they are
classified as class IIb.
The contra-angle handpieces is a non-invasive device intended for short-term use, and
not direct in contact with human body especially the heart or central system.The way
of administration of energy or exchanging energy may indirectly injure the tissues in
the mouth when misused by operators or device under condition of malfunction. The
device with low risk because of it’s site of application.
The contra-angle handpieces not intended to control or monitor the performance of
active therapeutic class IIb devices, or not intended directly to influence the
performance of such devices.
The contra-angle handpieces not intended to emit ionizing radiation for therapeutic
purposes, including devices which control or monitor such devices, or which directly
influence their performance.
The contra-angle handpieces is not intended for controlling, monitoring or directly
influencing the performance of active implantable devices.
Based on the above analysis, the device is classed as IIa.
19.Device subcategory
MDA 0311 Active non-implantable dental devices.
