Pure Global

Siemens MOBILETT Impact - HSA Registration DE0509351

Access comprehensive regulatory information for Siemens MOBILETT Impact in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509351 and owned by Siemens Healthcare GmbH. The device was registered on June 05, 2024.

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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS C
DE0509351
Siemens MOBILETT Impact
HSA Registration Number: DE0509351
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product 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.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0509351
Registration Date
June 05, 2024
Retention Due Date
June 04, 2025
Product Owner
Short Name
Siemens Healthcare GmbH
Address
HenkestraรŸe 127, 91052 Erlangen, GERMANY
Registrant
Address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Importer
Address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Model Information
Model Name(s)
Grid 3543Ezh JPI Trixell Pixium 3543EZh (MAX wi-D) Trixell Pixium 2430EZ (MAX mini) Mobilett Impact Mars1417VS X-Ray Tube Assembly
Model Identifier(s)
10860587 11105032 11343239 11647500 11647803 AS00511