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Dr. Fenyves und Gut Sonata Patient Recorder System - HSA Registration DE0509638

Access comprehensive regulatory information for Dr. Fenyves und Gut Sonata Patient Recorder System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509638 and owned by Dr. Fenyves und Gut Deutschland GmbH. The device was registered on August 07, 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.

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CLASS B
DE0509638
Dr. Fenyves und Gut Sonata Patient Recorder System
HSA Registration Number: DE0509638
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Product Description

The Patient Recorder is an acquisition system for measurement data. The measurement data can be saved in the internal memory and / or can be transmitted online to the PC. The Sonata Recorder is compatible with additional neuromodule which is used to record and transmit neurological and other signals for the differentiated diagnosis of sleep disorders and therapy control

Device Classification
Device Class
CLASS B
Medical Speciality Area
Neurology
Registration Information
Registration Number
DE0509638
Registration Date
August 07, 2024
Retention Due Date
August 06, 2025
Product Owner
Short Name
Dr. Fenyves und Gut Deutschland GmbH
Address
Daimlerstr.23, 72414 Rangendingen, Germany, GERMANY
Registrant
Address
11 LORONG 3 TOA PAYOH, BLOCK B JACKSON SQUARE, #01-13, SINGAPORE 319579
Importer
Address
11 LORONG 3 TOA PAYOH, JACKSON SQUARE, #01-13, SINGAPORE 319579
Model Information
Model Name(s)
PC-Software MSV Sonata Patient Recorder Sonata Neuro Module
Model Identifier(s)
925309 930010 930020