HSA · registration DE0510325

Fresenius FX Classix High-Flux Dialyser

Name: Fresenius FX Classix High-Flux Dialyser — HSA DE0510325
Creator: Fresenius Medical Care AG
Keywords: Fresenius FX Classix High-Flux Dialyser, Fresenius FX Classix High-Flux Dialyser, DE0510325, General Hospital, HSA

SingaporeGeneral HospitalClass CFresenius Medical Care AG

Verified

Official record identity

Registration number: DE0510325
Model name: FX50 classix Fresenius Helixone High-Flux Dialyser; FX60 classix Fresenius Helixone High-Flux Dialyser; FX80 classix Fresenius Helixone High-Flux Dialyser; FX100 classix Fresenius Helixone High-Flux Dialyser
Model identifier: F00002385; F00002386; F00002387; F00002388
Registration date: February 11, 2025
Source update date: August 05, 2025

Classification

Risk class: Class C
Published category: General Hospital

Published parties

Product owner: Fresenius Medical Care AG
Registrant / registration holder: FRESENIUS MEDICAL CARE SINGAPORE PTE. LTD.

Official description

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

Additional source fields

Product owner address: Else-Kroner-Str. 1, D-61352 Bad Homburg, Germany
Registrant address: 250 NORTH BRIDGE ROAD, #05-01, RAFFLES CITY TOWER, Singapore 179101

About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.