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Fresenius Kabi BioR flex 01 BS PF - HSA Registration DE0506895

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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CLASS B
DE0506895
Fresenius Kabi BioR flex 01 BS PF
HSA Registration Number: DE0506895
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Product Description

BS PF model for use at the patientโ€™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.

Device 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 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