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Fresenius BCM Body Composition Monitor - HSA Registration DE0500409

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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CLASS B
DE0500409
Fresenius BCM Body Composition Monitor
HSA Registration Number: DE0500409
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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.

Device 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 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