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Fresenius multiFiltrate kit Paed CRRT/SCUF - HSA Registration DE0018291

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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CLASS C
DE0018291
Fresenius multiFiltrate kit Paed CRRT/SCUF
HSA Registration Number: DE0018291
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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.

Device 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 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