Pure Global
Singapore HSA registration DE0503846

B. Braun Haemodialysis Liquid Concentrate (Acid)

Singapore flagSingapore·CLASS C·B. Braun Avitum AG·Registered November 22, 2019
Device classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0503846
Registration Date
November 22, 2019
Change Notification Approval Date
February 13, 2023
Retention Due Date
November 21, 2025
Product description
The indications below apply exclusively to the ready-to-use bicarbonate haemodialysis solution prepared from acid concentrate and bicarbonate concentrate following the specified dilution procedure: – Acute renal failure – Chronic renal failure – Hyperhydration – Intoxications – Compensation of acid-base and electrolyte balances – Adjustment of the blood / plasma / body temperature
Product Owner
Name
B. Braun Avitum AG
Short Name
B. Braun
Address
Schwarzenberger Weg 73-79, 34212 Melsungen, GERMANY
Registrant
Name
B. BRAUN SINGAPORE PTE LTD
Address
600 NORTH BRIDGE ROAD, PARKVIEW SQUARE, #15-05, SINGAPORE 188778
Importer
Name
B. BRAUN SINGAPORE PTE LTD
Address
600 NORTH BRIDGE ROAD, PARKVIEW SQUARE, #15-05, SINGAPORE 188778
Model information
Model Name(s)
NKFS-05 NKFS-05 NKFS-06 NKFS-06 NKFS-07 NKFS-07 NKFS-08 NKFS-08 NKFS-01X44 NKFS-01X44 NKFS-02X44 NKFS-02X44 NKFS-03X44 NKFS-03X44 NKFS-04X44 NKFS-04X44 NKFS-05X44 NKFS-05X44 NKFS-06X44 NKFS-06X44 NKFS-07X44 NKFS-07X44 NKFS-08X44 NKFS-08X44 NKFS-09 NKFS-010 NKFS-011 NKFS-06X44 NKFS-07X44 NKFS-08X44 NKFS-09X44 NKFS-010X44
Model Identifier(s)
3610871 3610872 3610873 3610874 3610875 3610876 3610877 3610878 3610901 3610902 3610903 3610904 3610905 3610906 3610907 3610908 3610909 3610910 3610911 3610912 3610913 3610914 3610915 3610919 3611066 3611067 3611068 3611069 3611070 3611071 3611072 3611073
About this record

Access comprehensive regulatory information for B. Braun Haemodialysis Liquid Concentrate (Acid) in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0503846 and owned by B. Braun Avitum AG. The device was registered on November 22, 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