Singapore HSA registration DE0507571
Physio-Assist SIMEOX
Singapore·CLASS B·PHYSIO-ASSIST·Registered December 05, 2022Device 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 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.
Product Owner
- Name
- PHYSIO-ASSIST
- 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
- Name
- BMEC PTE LTD
- 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
About this record
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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