Singapore HSA registration DE0505077
BMC Medical N5 Nasal Masks
Singapore·CLASS B·BMC Medical Co., Ltd.·Registered October 27, 2020Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0505077
- Registration Date
- October 27, 2020
- Change Notification Approval Date
- April 22, 2022
- Retention Due Date
- October 26, 2025
Product description
The N5 Nasal Mask channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or Bi-level system. The N5 Nasal Mask is: • To be used by adult patients (> 66 lb / 30 kg) for whom positive airway pressure therapy has been prescribed. • Intended for single-patient re-use in the home environment and multi-patient re-use in the hospital / institutional environment.
Product Owner
- Short Name
- BMC Medical Co., Ltd.
- Address
- Room 110 Tower A Fengyu Building, No.115 Fucheng Road Haidian, 100036 Beijing, CHINA
Registrant
- Address
- 7030 ANG MO KIO AVENUE 5, NORTHSTAR @ AMK, #04-20, SINGAPORE 569880
Importer
- Address
- 7030 ANG MO KIO AVENUE 5, NORTHSTAR @ AMK, #04-20, SINGAPORE 569880
Model information
- Model Name(s)
- Nasal Mask Nasal Mask Nasal Mask
- Model Identifier(s)
- N5 (L) N5 (M) N5 (S)
About this record
Access comprehensive regulatory information for BMC Medical N5 Nasal Masks in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505077 and owned by BMC Medical Co., Ltd.. The device was registered on October 27, 2020.
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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