Gambro AK 96® System - HSA Registration DE0005919
Access comprehensive regulatory information for Gambro AK 96® System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0005919 and owned by Gambro Lundia AB. The device was registered on January 07, 2011.
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.
The Gambro AK 96 dialysis machine is intended for use as a single patient machine to perform hemodialysis treatments of patients with renal failure or fluid overload upon prescription by a physician. Patient counselling and teaching of treatment techniques are directly under the supervision and discretion of the physician. The AK 96 dialysis machine is intended for the In-Center environment and for self-care, for example in home environment, on the condition that the hemodialysis is performed by a qualified and competent person, as prescribed by a physician.