Singapore HSA registration DE0505914
SEFAM SEFAM S.Box
Singapore·CLASS B·SEFAM·Registered June 23, 2021Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ear, Nose & Throat
Registration information
- Registration Number
- DE0505914
- Registration Date
- June 23, 2021
- Retention Due Date
- June 22, 2025
Product description
The SEFAM S.Box is designed for the treatment of Obstructive Sleep Apnea–Hypopnea Syndrome (OSAHS) in patients over 30 kg, who breathe spontaneously. It can be used at home or in healthcare centers (hospital or clinics). This device is not intended to provide assistance to vital functions.
Product Owner
- Name
- SEFAM
- Short Name
- SEFAM
- Address
- 144 Avenue Charles de Gaulle, 92200 Neuilly Sur Seine, France, FRANCE
Registrant
- Address
- 4 LENG KEE ROAD, SIS BUILDING, #03-03, SINGAPORE 159088
Importer
- Address
- 4 LENG KEE ROAD, SIS BUILDING, #03-03, SINGAPORE 159088
Model information
- Model Name(s)
- SEFAM S.BOX Module WIFI S.Box HEATED HUMIDIFIER S.BOX S.BOX HEATED TUBE RESERVOIR S.BOX - S.BOX Humidifier Chamber S.BOX 15MM STANDARD TUBE SLEEPBOX 22MM STANDARD TUBE 50 INLET AIR FILTER SEFAM Analyze
- Model Identifier(s)
- M-116412 M-116900 M-216430-06 M-216430-07 M-216430-15 M-261000-05 M-261000-06 M-315940-01 SEFAM Analyze
About this record
Access comprehensive regulatory information for SEFAM SEFAM S.Box in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505914 and owned by SEFAM. The device was registered on June 23, 2021.
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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