Singapore HSA registration DE0510325
Fresenius FX Classix High-Flux Dialyser
Singapore·CLASS C·Fresenius Medical Care AG·Registered February 11, 2025Device 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 description
FX classix dialysers are designed for single use in chronic haemodialysis or haemo(dia)filtration respectively.
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
About this record
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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