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Singapore HSA registration DE0504137

B. Braun Dialog iQ® Dialysis Machine

Singapore flagSingapore·CLASS C·B. Braun Avitum AG·Registered February 20, 2020
Device classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0504137
Registration Date
February 20, 2020
Change Notification Approval Date
February 17, 2025
Retention Due Date
February 19, 2026
Product description
The Dialog iQ is an equipment for extracorporeal blood treatments to administer and remove substances and body fluids, intended to be used for performing and monitoring hemodialysis treatments. Depending on the model, the following types of therapy can be carried out with the machine: • Hemodialysis (HD) • Hemodiafiltration (HDF) • Hemofiltration (HF) • Sequential (SEQ)/isolated ultrafiltration (ISO UF). The machine is indicated for patients, who need hemodialysis treatments due to renal insufficiency in chronic kidney disease and/or acute kidney injury.
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)
Dialog iQ Dialog iQ Dialog iQ Dialog iQ Option CCS Option HCT Sensor Option Staff Call Option KUFmax Option bioLogic Fusion Option DIN WAN
Model Identifier(s)
7104013 710401A 7104072 710407A 7104196 7104270 7104315 7104316 7104324 7104330
About this record

Access comprehensive regulatory information for B. Braun Dialog iQ® Dialysis Machine in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0504137 and owned by B. Braun Avitum AG. The device was registered on February 20, 2020.

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