Singapore HSA registration DE0018966
Fresenius FX Helixone® Dialyzer
Singapore·CLASS C·Fresenius Medical Care AG·Registered February 14, 2017Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Gastroenterology & Urology
Registration information
- Registration Number
- DE0018966
- Registration Date
- February 14, 2017
- Change Notification Approval Date
- May 02, 2024
- Retention Due Date
- February 13, 2026
Product description
FX Low-Flux dialysers are designed for single use in chronic haemodialysis.
Product Owner
- Short Name
- Fresenius Medical Care AG
- Address
- Else-Kroner-Str. 1, 61352 Bad Homburg, GERMANY
Registrant
- Address
- 250 NORTH BRIDGE ROAD, RAFFLES CITY TOWER, #05-01, SINGAPORE 179101
Importer
- Address
- 250 NORTH BRIDGE ROAD, RAFFLES CITY TOWER, #05-01, SINGAPORE 179101
Model information
- Model Name(s)
- FX8 FX10 FX5
- Model Identifier(s)
- 5004731 5004741 5004831
About this record
Access comprehensive regulatory information for Fresenius FX Helixone® Dialyzer in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0018966 and owned by Fresenius Medical Care AG. The device was registered on February 14, 2017.
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C