Singapore HSA registration DE0510354
SEFAM Néa CPAP System
Singapore·CLASS B·SEFAM·Registered February 18, 2025Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0510354
- Registration Date
- February 18, 2025
- Retention Due Date
- February 17, 2026
Product description
Néa is Positive Pressure medical device connected by a flexible tube to a mask worn by a patient suffering from obstructive sleep apneas and hypopneas during sleep. The device delivers a continuous flow of air to avoid upper airway obstruction during sleep.
Product Owner
- Name
- SEFAM
- Short Name
- SEFAM
- Address
- 144 Avenue Charles de Gaulle, 92200 NEUILLY SUR SEINE, FRANCE
Registrant
- Address
- 116 CHANGI ROAD, WIS@CHANGI, #04-05, SINGAPORE 419718
Model information
- Model Name(s)
- Néa Info Néa Auto S.Box heated tube Néa H2O CPAP tubing Sefam S.Box 15mm standard tube S.Box 22mm standard tube
- Model Identifier(s)
- M-117011 M-117012 M-216430-07 M-217030-01 M-261000-04 M-261000-05 M-261000-06
About this record
Access comprehensive regulatory information for SEFAM Néa CPAP 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 DE0510354 and owned by SEFAM. The device was registered on February 18, 2025.
This page provides complete registration details including product owner information, registrant details, 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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