Pure Global
Singapore HSA registration DE0017717

Fresenius multiFiltrate Kit

Singapore flagSingapore·CLASS C·Fresenius Medical Care AG·Registered December 11, 2015
Device classification
Device Class
CLASS C
Medical Speciality Area
Gastroenterology & Urology
HSA Product Code
HSAMDC00110
HS Code
84212910
Registration information
Registration Number
DE0017717
Registration Date
December 11, 2015
Change Notification Approval Date
May 02, 2024
Retention Due Date
December 10, 2025
Product description
Fresenius multiFiltrate Kit is for continuous renal replacement therapy. Ultraflux AV 600S and AV1000S are designed for single use in acute dialysis with machine assisted continuous veno-venous haemofiltration, haemodialysis and haemodiafiltration (CVVH, CVVHD, CVVHDF). AV600S is also suitable for a non-machine assisted continuous arterio-venous haemofiltration or haemodialysis (CAVH, CAVHD). AV1000S is specifically recommended for high volume CVVH/CVVHDF. Ultraflux EMiC2 are designed for single use in acute dialysis with machine assisted continuous veno-venous haemodialysis (CVVHD) as well as for the SLEDD- therapy (Slow Extended Daily Dialysis). Blood line/ Tubing systems (cassette multifiltrate, cassette CiCa multifiltrate, Dialysate system multifiltrate) are intended for single use only for extracorporeal blood purification.
Product Owner
Name
Fresenius Medical Care AG
Short Name
Fresenius Medical Care AG
Address
Else-Kroner-Str. 1, 61352 Bad Homburg, GERMANY
Registrant
Name
FRESENIUS MEDICAL CARE SINGAPORE PTE. LTD.
Address
250 NORTH BRIDGE ROAD, RAFFLES CITY TOWER, #05-01, SINGAPORE 179101
Importer
Name
FRESENIUS MEDICAL CARE SINGAPORE PTE. LTD.
Address
250 NORTH BRIDGE ROAD, RAFFLES CITY TOWER, #05-01, SINGAPORE 179101
Model information
Model Name(s)
Fresenius ultraflux AV600S Fresenius Ultraflux AV 1000S Fresenius Ultraflux EmiC2 Fresenius Dialysate system multifiltrate Fresenius multiFiltrate cassette Fresenius multiFiltrate Ci-Ca Cassette Fresenius multiFiltrate Kit 3 CVVHD 600 Fresenius multiFiltrate Kit Ci-Ca CVVHD 1000 Fresenius multiFiltrate Kit Ci-Ca CVVHD EMIC® 2 Fresenius multiFiltrate Kit CVVHD EMiC 2 Fresenius Ci Ca Dialysate system multiFiltrate
Model Identifier(s)
5007361 5008981 5009771 5016751 5016801 5017541 5038921 5039011 F00001172 F00001173 F00003434
About this record

Access comprehensive regulatory information for Fresenius multiFiltrate Kit in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0017717 and owned by Fresenius Medical Care AG. The device was registered on December 11, 2015.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C