Singapore HSA registration DE0508010
Fresenius Crit-Line IV System
Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0508010
- Registration Date
- April 18, 2023
- Retention Due Date
- April 17, 2026
Product description
The Crit-Line IV System is used to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume. The Crit-Line Clip (CLiC) measures hematocrit, percent change in blood volume and oxygen saturation in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the dialysis technician. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e. increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting.
Product Owner
- Short Name
- Fresenius Medical Care North America
- Address
- 920 Winter Street, Waltham, MA 02451, UNITED STATES
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)
- Crit-Line Clip (CLiC) CRIT-LINE CLiC Blood Chamber Crit-Line IV Monitor
- Model Identifier(s)
- CL10041001 CL10041021 CL10051001
About this record
Access comprehensive regulatory information for Fresenius Crit-Line IV System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508010 and owned by Fresenius Medical Care North America. The device was registered on April 18, 2023.
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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