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Singapore HSA registration DE0502276

B. Braun OMNIset® TPE

Singapore flagSingapore·CLASS B·B. Braun Avitum AG·Registered October 18, 2018
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0502276
Registration Date
October 18, 2018
Change Notification Approval Date
June 04, 2024
Retention Due Date
October 17, 2025
Product description
The OMNIset® TPE is designed to be used exclusively with the OMNI®. OMNIset® TPE is intended to perform therapeutic plasma exchange for patients where removal of plasma components is indicated. The OMNIset® TPE is indicated to be used in a variety of diseases where therapeutic plasma exchange is indicated in adult patients (weight = 30kg).
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)
OMNIset® TPE OMNIset® TPE
Model Identifier(s)
7211153 7211154
About this record

Access comprehensive regulatory information for B. Braun OMNIset® TPE in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0502276 and owned by B. Braun Avitum AG. The device was registered on October 18, 2018.

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