HSA · registration DE0017717Fresenius multiFiltrate Kit
- Registration number
- DE0017717
- Model name
- 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
- 5007361; 5008981; 5009771; 5016751; 5016801; 5017541; 5038921; 5039011; F00001172; F00001173; F00003434
- Registration date
- December 11, 2015
- Source update date
- May 02, 2024
- Risk class
- Class C
- Product owner
- Fresenius Medical Care AG
- Registrant / registration holder
- FRESENIUS MEDICAL CARE SINGAPORE PTE. LTD.
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 address
- Else-Kroner-Str. 1, 61352 Bad Homburg, Germany
- Registrant address
- 250 NORTH BRIDGE ROAD, #05-01, RAFFLES CITY TOWER, Singapore 179101
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.