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Physio-Assist SIMEOX - HSA Registration DE0507571

Access comprehensive regulatory information for Physio-Assist SIMEOX in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507571 and owned by PHYSIO-ASSIST. The device was registered on December 05, 2022.

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
DE0507571
Physio-Assist SIMEOX
HSA Registration Number: DE0507571
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Product Description

Indicated as an airway secretion clearance device that helps liquefying and transporting secretions from the lungs so that they can then be cleared by coughing. The Simeox is indicated for adults and pediatric patients suffering from a lung disease and who have difficulty in clearing bronchial secretions.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0507571
Registration Date
December 05, 2022
Change Notification Approval Date
June 26, 2023
Retention Due Date
December 04, 2025
Product Owner
Short Name
PHYSIO-ASSIST
Address
31 Parc du Golf - CS 90519, 13593 AIX-EN-PROVENCE, FRANCE
Registrant
Address
7030 ANG MO KIO AVENUE 5, NORTHSTAR @ AMK, #04-20, SINGAPORE 569880
Importer
Address
82 UBI AVENUE 4, EDWARD BOUSTEAD CENTRE, #08-01, SINGAPORE 408832
Model Information
Model Name(s)
SIMEOX_H_EU airway clearance device Expiratory kit, 10 uses Expiratory kit, 25 uses
Model Identifier(s)
SIMEOX_H_EU TUB10_EU TUB25_EU