ANNEX XVI
LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE REFERRED TO IN ARTICLE 1(2)
1. |
Contact lenses or other items intended to be introduced into or onto the eye.打算將隱形眼鏡或其他物品引入眼睛或眼睛內的物品。 |
2. |
Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts with the exception of tattooing products and piercings.旨在通過外科手術手段完全或部分引入人體的產品,目的是修飾身體部位的解剖結構或固定方式(紋身產品和穿孔除外) |
3. |
Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing.打算通過皮下,粘膜下或皮內註射或其他方式用於面部或其他皮膚或粘膜填充的物質,物質組合或物品,但不用於紋身的物質。 |
4. |
Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.旨在減少,去除或破壞脂肪組織的設備,例如抽脂,脂解或脂肪成形術的設備。 |
5. |
High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment.打算在人體上使用的高強度電磁輻射(例如,紅外,可見光和紫外線)發射設備,包括相干和非相干光源,單色和廣譜光源,例如激光器和強脈衝光設備,用於皮膚重鋪,紋身或脫毛或其他皮膚治療。 |
6. |
Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain.用於大腦刺激的設備,該設備施加電流或磁場或電磁場,這些電流或磁場可以穿透顱骨,以改變大腦的神經元活動。 |
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