Gambro AK 98 Dialysis Machine - HSA Registration DE0018627
Access comprehensive regulatory information for Gambro AK 98 Dialysis Machine in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0018627 and owned by Gambro Lundia AB. The device was registered on October 04, 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.
The AK 98 dialysis machine is intended for use as a single patient machine to perform haemodialysis treatments of patients with renal failure or fluid overload upon prescription by a physician. Patient counseling and teaching of treatment techniques are directly under the supervision and discretion of the physician. The AK 98 dialysis machine is intended for the in-center environment and care in a home healthcare environment.