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Fresenius Medical Care Sodium Citrate 4% w/v Safe Lock - HSA Registration DE0503793

Access comprehensive regulatory information for Fresenius Medical Care Sodium Citrate 4% w/v Safe Lock in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0503793 and owned by Fresenius Medical Care AG. The device was registered on November 05, 2019.

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
DE0503793
Fresenius Medical Care Sodium Citrate 4% w/v Safe Lock
HSA Registration Number: DE0503793
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Product Description

Sodium citrate 4% solution is intended for regional anticoagulation in continuous renal replacement therapies (CRRT) in adults: - Continuous veno-venous haemodialysis (Ci-Caยฎ CVVHD) - Post-dilution continuous veno-venous haemodiafiltration (Ci-Caยฎ post CVVHDF) Sodium citrate 4% solution must only be used with Fresenius Medical Care CRRT devices multiFiltrate and multiFiltratePRO for the mentioned blood processing therapies, and having integrated pumps to administer citrate and calcium.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0503793
Registration Date
November 05, 2019
Change Notification Approval Date
May 02, 2024
Retention Due Date
November 04, 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)
Sodium Citrate 4% w/v
Model Identifier(s)
F00008105