Singapore HSA registration DE0018291
Fresenius multiFiltrate kit Paed CRRT/SCUF
Singapore·CLASS C·Fresenius Medical Care AG·Registered June 27, 2016Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Gastroenterology & Urology
Registration information
- Registration Number
- DE0018291
- Registration Date
- June 27, 2016
- Change Notification Approval Date
- May 02, 2024
- Retention Due Date
- June 26, 2025
Product description
Kit for continuous renal replacement. Paed CRRT/SCUF (bloodlines & tubing systems Bloodline/Tubing systems are intended for single use only for extracorporeal blood purification. Ultraflux AV paed-filters are designed for single use in acute dialysis with machine-assisted continuous veno-venous haemofiltration, haemodialysis & haemodiafiltration (CVVH, CVVHD, CVVHDF). The filters are specifically meant for use in infants with a body weight of less than 10kg.
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)
- Ultraflux AV Paed multiFiltrate paed CRRT/SCUF Set multiFiltrate kit Paed CRRT/SCUF
- Model Identifier(s)
- 5008231 5017751 5039051
About this record
Access comprehensive regulatory information for Fresenius multiFiltrate kit Paed CRRT/SCUF in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0018291 and owned by Fresenius Medical Care AG. The device was registered on June 27, 2016.
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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