HSA · registration DE0018966

Fresenius FX Helixone® Dialyzer

Name: Fresenius FX Helixone® Dialyzer — HSA DE0018966
Creator: Fresenius Medical Care AG
Keywords: Fresenius FX Helixone® Dialyzer, Fresenius FX Helixone® Dialyzer, DE0018966, Gastroenterology & Urology, HSA

SingaporeGastroenterology & UrologyClass CFresenius Medical Care AG

Verified

Official record identity

Registration number: DE0018966
Model name: FX8; FX10; FX5
Model identifier: 5004731; 5004741; 5004831
Registration date: February 14, 2017
Source update date: May 02, 2024

Classification

Risk class: Class C
Published category: Gastroenterology & Urology

Published parties

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

Official description

FX Low-Flux dialysers are designed for single use in chronic haemodialysis.

Additional source fields

Product owner address: Else-Kroner-Str. 1, 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.