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Singapore HSA registration DE0503870

B. Braun DiaStream® iQ Bloodlines

Singapore flagSingapore·CLASS B·B. Braun Avitum AG·Registered November 29, 2019
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0503870
Registration Date
November 29, 2019
Change Notification Approval Date
March 10, 2025
Retention Due Date
November 28, 2025
Product description
The DiaStream® iQ is intended to be used exclusively with the Dialog® iQ machine. DiaStream® iQ bloodlines in combination with Dialog® iQ machine are intended for hemodialysis treatments: Hemodialysis (HD), Hemodiafiltration (HDF), Hemofiltration (HF), sequential (SEQ)/ isolated ultrafiltration (ISO UF). They are intended to provide the extracorporeal blood circuit from the patient’s vascular access to the dialyzer and back in combination with the hemodialysis machines. The DiaStream® iQ bloodlines are indicated for patients, who need hemodialysis treatments with chronic hemodialysis machines 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)
2000 ml Drain bag Y Single needle adapter DiaStream iQ Classic DiaStream iQ Premium DiaStream iQ Classic DiaStream iQ Premium DiaStream iQ Classic DiaStream iQ Accessory DiaStream iQ Premium Reinfusion Adapter
Model Identifier(s)
7020457 7211117 7211124 7211125 7211126 7211127 7211128 7211130 7211183 7211412
About this record

Access comprehensive regulatory information for B. Braun DiaStream® iQ Bloodlines in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0503870 and owned by B. Braun Avitum AG. The device was registered on November 29, 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 B