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Fresenius FX Helixone® Dialyzer - HSA Registration DE0018966

Access comprehensive regulatory information for Fresenius FX Helixone® Dialyzer in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0018966 and owned by Fresenius Medical Care AG. The device was registered on February 14, 2017.

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
DE0018966
Fresenius FX Helixone® Dialyzer
HSA Registration Number: DE0018966
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Product Description

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

Device Classification
Device Class
CLASS C
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0018966
Registration Date
February 14, 2017
Change Notification Approval Date
May 02, 2024
Retention Due Date
February 13, 2026
Product Owner
Short Name
Fresenius Medical Care AG
Address
Else-Kroner-Str. 1, 61352 Bad Homburg, GERMANY
Registrant
Address
250 NORTH BRIDGE ROAD, RAFFLES CITY TOWER, #05-01, SINGAPORE 179101
Importer
Address
250 NORTH BRIDGE ROAD, RAFFLES CITY TOWER, #05-01, SINGAPORE 179101
Model Information
Model Name(s)
FX8 FX10 FX5
Model Identifier(s)
5004731 5004741 5004831