Singapore HSA registration DE0508449
B. Braun Acidic Bicarbonate Hemodialysis Concentrates
Singapore·CLASS C·B. Braun Avitum AG·Registered September 04, 2023Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0508449
- Registration Date
- September 04, 2023
- Retention Due Date
- September 03, 2025
Product description
The indications below apply exclusively to the ready-to-use hemodialysis solution prepared from alkaline and acidic bicarbonate hemodialysis concentrates diluted as directed: – Acute renal failure – Chronic renal failure – Hyperhydration – Intoxications – Compensation of acid-base and electrolyte balances – Adjustment of the blood / plasma / body temperature.
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)
- SW 806 A SW 808 A SW 813 A SW 475 A SW 802 A SW 803 A SW 810 A SW 820 A SW 830 A SW 840 A SW 841 A SW 842 A SW 375 A SW 376 A SW 163 A SW 127 A SW 380 A SW 139 A SW 285 A SW 195 A SW 393 A SW 286 A SW 178 A SW 381 A SW 415 A SW 479 A SW 482 A SW 843 A SW 844 A SW 845 A
- Model Identifier(s)
- 8018 8019 8020 8021 8026 8027 8031 8032 8033 8034 8035 8040 8043 8044 8045 8046 8047 8048 8049 8056 8057 8059 8060 8061 8071 8072 8073 8090 8091 8092
About this record
Access comprehensive regulatory information for B. Braun Acidic Bicarbonate Hemodialysis Concentrates in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508449 and owned by B. Braun Avitum AG. The device was registered on September 04, 2023.
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