Singapore HSA registration DE0500409
Fresenius BCM Body Composition Monitor
Singapore·CLASS B·Fresenius Medical Care AG·Registered April 01, 2016Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Gastroenterology & Urology
Registration information
- Registration Number
- DE0500409
- Registration Date
- April 01, 2016
- Change Notification Approval Date
- May 02, 2024
- Retention Due Date
- March 31, 2026
Product description
The BCM - Body Composition Monitor assists the physician in assessing the hydration status by a bioimpedance spectroscopy measurement of the body composition from which the level of overhydration can be derived. Apart from the hydration status, the device also determines the patient's nutritional condition. The device permits continuous monitoring of the body composition and provides an objective indicator for the nutritional condition: the LTI (Lean Tissue Index) and the FTI (Fat Tissue Index). The BCM - Body Composition Monitor also determines of the urea distribution volume to calculate the dialysis dose (Kt/V). The BCM - Body Composition Monitor is intended for screening and monitoring of patients with renal diseases within the scope of dialysis therapy and extracorporeal therapies. It can be used in dialysis centers, hospitals, medical practices.
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)
- BCM Porter BCM Body Composition Monitor Patient Card Electrode Connecting Cable Disposable electrodes External PC Card Reader Testbox AC Adaptor with Country Adaptor Case for BCM Disposable electrodes for children Fluid Management Tool
- Model Identifier(s)
- 6297431 H022011 M348601 M351351 M351431 M374851 M390441 M390461 M401791 M416561 M431701
About this record
Access comprehensive regulatory information for Fresenius BCM Body Composition Monitor in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0500409 and owned by Fresenius Medical Care AG. The device was registered on April 01, 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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