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BMC Medical N5 Nasal Masks - HSA Registration DE0505077

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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CLASS B
DE0505077
BMC Medical N5 Nasal Masks
HSA Registration Number: DE0505077
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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: โ€ข To be used by adult patients (> 66 lb / 30 kg) for whom positive airway pressure therapy has been prescribed. โ€ข Intended for single-patient re-use in the home environment and multi-patient re-use in the hospital / institutional environment.

Device 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 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)