HSA · registration DE0018291

Fresenius multiFiltrate kit Paed CRRT/SCUF

Name: Fresenius multiFiltrate kit Paed CRRT/SCUF — HSA DE0018291
Creator: Fresenius Medical Care AG
Keywords: Fresenius multiFiltrate kit Paed CRRT/SCUF, Fresenius multiFiltrate kit Paed CRRT/SCUF, DE0018291, Gastroenterology & Urology, HSA

SingaporeGastroenterology & UrologyClass CFresenius Medical Care AG

Verified

Official record identity

Registration number: DE0018291
Model name: Ultraflux AV Paed; multiFiltrate paed CRRT/SCUF Set; multiFiltrate kit Paed CRRT/SCUF
Model identifier: 5008231; 5017751; 5039051
Registration date: June 27, 2016
Source update date: May 02, 2024

Classification

Risk class: Class C
Published category: Gastroenterology & Urology

Published parties

Product owner: Fresenius Medical Care AG
Registrant / registration holder: FRESENIUS MEDICAL CARE SINGAPORE PTE. LTD.

Official 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.

Additional source fields

Product owner address: Else-Kroner-Str. 1, 61352 Bad Homburg, Germany
Registrant address: 250 NORTH BRIDGE ROAD, #05-01, RAFFLES CITY TOWER, Singapore 179101

About this record

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.