Pure Global AI
HSA · registration DE0500409

Fresenius BCM Body Composition Monitor

SingaporeGastroenterology & UrologyClass BFresenius Medical Care AG
Verified
Official record identity
Registration number
DE0500409
Model name
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
6297431; H022011; M348601; M351351; M351431; M374851; M390441; M390461; M401791; M416561; M431701
Registration date
April 01, 2016
Source update date
May 02, 2024
Classification
Risk class
Class B
Official value: CLASS B
Published category
Gastroenterology & Urology
View exact category matches →
Published parties
Product owner
Fresenius Medical Care AG
Registrant / registration holder
FRESENIUS MEDICAL CARE SINGAPORE PTE. LTD.
Official 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.

Additional source fields
Product owner address
Else-Kroner-Str. 1, 61352 Bad Homburg, Germany
Registrant address
250 NORTH BRIDGE ROAD, #05-01, RAFFLES CITY TOWER, Singapore 179101
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.