Singapore HSA registration DE0503793
Fresenius Medical Care Sodium Citrate 4% w/v Safe Lock
Singapore·CLASS C·Fresenius Medical Care AG·Registered November 05, 2019Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0503793
- Registration Date
- November 05, 2019
- Change Notification Approval Date
- May 02, 2024
- Retention Due Date
- November 04, 2025
Product description
Sodium citrate 4% solution is intended for regional anticoagulation in continuous renal replacement therapies (CRRT) in adults: - Continuous veno-venous haemodialysis (Ci-Ca® CVVHD) - Post-dilution continuous veno-venous haemodiafiltration (Ci-Ca® post CVVHDF) Sodium citrate 4% solution must only be used with Fresenius Medical Care CRRT devices multiFiltrate and multiFiltratePRO for the mentioned blood processing therapies, and having integrated pumps to administer citrate and calcium.
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)
- Sodium Citrate 4% w/v
- Model Identifier(s)
- F00008105
About this record
Access comprehensive regulatory information for Fresenius Medical Care Sodium Citrate 4% w/v Safe Lock in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0503793 and owned by Fresenius Medical Care AG. The device was registered on November 05, 2019.
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