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HSA · registration DE0509351

Siemens MOBILETT Impact

SingaporeRadiology / ImagingClass CSiemens Healthcare GmbH
Verified
Official record identity
Registration number
DE0509351
Model name
Grid 3543Ezh JPI; Trixell Pixium 3543EZh (MAX wi-D); Trixell Pixium 2430EZ (MAX mini); Mobilett Impact; Mars1417VS; X-Ray Tube Assembly
Model identifier
10860587; 11105032; 11343239; 11647500; 11647803; AS00511
Registration date
June 05, 2024
Classification
Risk class
Class C
Official value: CLASS C
Published category
Radiology / Imaging
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Published parties
Product owner
Siemens Healthcare GmbH
Registrant / registration holder
SIEMENS HEALTHCARE PTE. LTD.
Official description

MOBILETT Impact is a mobile device intended to visualize anatomical structures of human beings by converting an X ray pattern into a visible image. MOBILETT Impact enables free radiographic exposures of the whole body, for example of the head, spinal column, abdomen, thorax (lungs), internal organs and extremities, whereas thorax (lungs) is the main application of a mobile X-ray unit. The product is not intended for mammography examinations.

Additional source fields
Product owner address
Henkestraße 127, 91052 Erlangen, Germany
Registrant address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, Singapore 348615
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.