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B. Braun Calcium-Free Bicarbonate Solution with Potassium - HSA Registration DE0502762

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.

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CLASS C
DE0502762
B. Braun Calcium-Free Bicarbonate Solution with Potassium
HSA Registration Number: DE0502762
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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.

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 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