Device Dossier
Needle, acupuncture, single-use
Device Dossier for Needle, acupuncture, single-use (Needle, acupuncture, single-use, Class IIa, sponsor NeedlePro). ARTG record, intended purpose, GMDN…
- GMDN category: Needle, acupuncture, single-use
Intended purpose
The manufacturers intended purpose for Dongbang acupuncture needles is to use these pre sterilised single use and disposable needles on acupuncture points and associated areas of the body for the purposes of therapy and healing. DongBang needles are made of high quality surgical stainless steel wire using advanced grinding technology and quality control systems. The needles are packed in facilities which are established and operated in such a way that meet KGMP (Korea Good Manufacturing Procedure)standards. The sterilization process takes place within the production factory. All procedures are rigorously controlled from start to finish. Quality control ensures that the standards of CE, FDA and ISO9001/13485 are rigidly adhered to.