Singapore HSA registration DE0502762
B. Braun Calcium-Free Bicarbonate Solution with Potassium
Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0502762
- Registration Date
- February 07, 2019
- Change Notification Approval Date
- November 25, 2023
- Retention Due Date
- February 06, 2026
Product description
B. Braun Bicarbonate Calcium-Free Solution is a dialysis solution for continuous veno-venous haemodialysis (CVVHD) during citrate anticoagulation with a Citrate Anticoagulation Solution ACD-A or Sodium Citrate 4% and with a parallel calcium substitution. B. Braun Bicarbonate Calcium-Free Solution must only be used in combination with B. Braun machines for continuous haemodialysis with integrated pumps for citrate and calcium infusions.
Product Owner
- Short Name
- B. Braun
- Address
- Schwarzenberger Weg 73-79, 34212 Melsungen, GERMANY
Registrant
- Address
- 600 NORTH BRIDGE ROAD, PARKVIEW SQUARE, #15-05, SINGAPORE 188778
Importer
- Address
- 600 NORTH BRIDGE ROAD, PARKVIEW SQUARE, #15-05, SINGAPORE 188778
Model information
- Model Name(s)
- B. Braun Calcium-Free Bicarbonate Solution with 4 mmol/L Potassium B. Braun Calcium-Free Bicarbonate Solution with 2 mmol/L Potassium
- Model Identifier(s)
- 4580 4581
About this record
Access comprehensive regulatory information for B. Braun Calcium-Free Bicarbonate Solution with Potassium in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0502762 and owned by B. Braun Avitum AG. The device was registered on February 07, 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