Singapore HSA registration DE0506895
Fresenius Kabi BioR flex 01 BS PF
Singapore·CLASS B·Fresenius Kabi AG·Registered May 30, 2022Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Hematology
Registration information
- Registration Number
- DE0506895
- Registration Date
- May 30, 2022
- Retention Due Date
- May 29, 2025
Product description
BS PF model for use at the patient’s bedside, with prefilter. Device is intended for leukocyte reduction of one red cell concentrates unit, with the aim to prevent or reduce patient immunization and/or transfusion reactions/infections caused by donor leukocytes. Device is not intended to be directly used by patients. Device is intended to be handled by qualified and properly trained technical and/or medical staff only and to be used one only for single patient, for patients of all ages.
Product Owner
- Short Name
- Fresenius Kabi
- Address
- 61346 Bad Homburg, GERMANY
Registrant
- Address
- 238A THOMSON ROAD, NOVENA SQUARE, #24-03/05, SINGAPORE 307684
Importer
- Address
- 238A THOMSON ROAD, NOVENA SQUARE, #24-03/05, SINGAPORE 307684
Model information
- Model Name(s)
- BioR flex 01 BS PF
- Model Identifier(s)
- AW00911
About this record
Access comprehensive regulatory information for Fresenius Kabi BioR flex 01 BS PF in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506895 and owned by Fresenius Kabi AG. The device was registered on May 30, 2022.
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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