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Singapore HSA registration DE0504758

BMC Respiratory High-flow Therapy Device H-80 Series

Singapore flagSingapore·CLASS B·BMC Medical Co., Ltd.·Registered July 29, 2020
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0504758
Registration Date
July 29, 2020
Change Notification Approval Date
January 06, 2021
Retention Due Date
July 28, 2025
Product description
H-80 series humidifier is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases. This device is for patients by prescription in the home or hospital/institutional environment. The device is only allowed to be used after the physician provides guidance for the patient and targeted setting of the device; the physician should ensure that the patient understands all functions and methods of operation of the device.
Product Owner
Name
BMC Medical Co., Ltd.
Short Name
BMC Medical Co., Ltd.
Address
Room 110 Tower A Fengyu Building, No.115 Fucheng Road Haidian, 100036 Beijing, CHINA
Registrant
Name
MEDWORX INTERNATIONAL PRIVATE LIMITED
Address
7030 ANG MO KIO AVENUE 5, NORTHSTAR @ AMK, #04-20, SINGAPORE 569880
Importer
Name
MEDWORX INTERNATIONAL PRIVATE LIMITED
Address
7030 ANG MO KIO AVENUE 5, NORTHSTAR @ AMK, #04-20, SINGAPORE 569880
Model information
Model Name(s)
Respiratory High-Flow Therapy Device Respiratory High-Flow Therapy Device Respiratory High-Flow Therapy Device Heated Breathing Tube Nasal Cannula Nasal Cannula Nasal Cannula Nasal Cannula
Model Identifier(s)
H-80A H-80AS H-80M LH2 NC10L NC10M NC10S NC10XS
About this record

Access comprehensive regulatory information for BMC Respiratory High-flow Therapy Device H-80 Series in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504758 and owned by BMC Medical Co., Ltd.. The device was registered on July 29, 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B