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Singapore HSA registration DE0508665

B. Braun DiaStream®

Singapore flagSingapore·CLASS B·B. Braun Avitum AG·Registered November 15, 2023
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0508665
Registration Date
November 15, 2023
Retention Due Date
November 14, 2025
Product description
The DiaStream® bloodlines are intended to be used exclusively with the dialysis machines indicated in label. DiaStream® bloodlines in combination with the dialysis machines indicated in label 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.
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)
DiaStream® Premium DiaStream® Classic Universal
Model Identifier(s)
7211511 7211513
About this record

Access comprehensive regulatory information for B. Braun DiaStream® in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508665 and owned by B. Braun Avitum AG. The device was registered on November 15, 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.

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