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Fresenius FX Classix High-Flux Dialyser - HSA Registration DE0510325

Access comprehensive regulatory information for Fresenius FX Classix High-Flux Dialyser in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510325 and owned by Fresenius Medical Care AG. The device was registered on February 11, 2025.

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 C
DE0510325
Fresenius FX Classix High-Flux Dialyser
HSA Registration Number: DE0510325
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Product Description

FX classix dialysers are designed for single use in chronic haemodialysis or haemo(dia)filtration respectively.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0510325
Registration Date
February 11, 2025
Retention Due Date
February 10, 2026
Product Owner
Short Name
Fresenius
Address
Else-Kroner-Str. 1, D-61352 Bad Homburg, GERMANY
Registrant
Address
250 NORTH BRIDGE ROAD, RAFFLES CITY TOWER, #05-01, SINGAPORE 179101
Importer
Address
238A THOMSON ROAD, NOVENA SQUARE, #24-03/05, SINGAPORE 307684 250 NORTH BRIDGE ROAD, RAFFLES CITY TOWER, #05-01, SINGAPORE 179101
Model Information
Model Name(s)
FX60 classix Fresenius Helixone High-Flux Dialyser FX80 classix Fresenius Helixone High-Flux Dialyser FX100 classix Fresenius Helixone High-Flux Dialyser
Model Identifier(s)
F00002386 F00002387 F00002388