Palodex Orthopantomograph™ OP300 Digital Imaging Systems - HSA Registration DE0017771
Access comprehensive regulatory information for Palodex Orthopantomograph™ OP300 Digital Imaging Systems in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0017771 and owned by PaloDEx Group Oy. The device was registered on January 12, 2016.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
OP300 must only be used and operated by healthcare professionals and other qualified professionals. OP300 must only be used to take panoramic, cephalometric and 3D images of the dento-maxillofacial complex of the human skull. It must not be used to take images of any other part of the human body. Panoramic and 3D exposures should not be used if conventional intraoral radiographic images (like biteviewing exposures) would be sufficient. Cone beam computed tomography images are not adequate for the analysis of soft tissue.