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ABMRC BiWaze Cough - HSA Registration DE0507115

Access comprehensive regulatory information for ABMRC BiWaze Cough in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507115 and owned by ABMRC, LLC. The device was registered on July 27, 2022.

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
DE0507115
ABMRC BiWaze Cough
HSA Registration Number: DE0507115
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Product Description

This device is designed for use on patients unable to cough or clear secretions effectively due to reduced peak cough expiratory flow, resulting from high spinal cord injuries, neuromuscular deficits or severe fatigue associated with intrinsic lung disease. This device is intended for use in hospital, institutional setting or in home on adult patients and paediatric patients 3 years old and above

Device Classification
Device Class
CLASS B
Medical Speciality Area
Anaesthesiology
Registration Information
Registration Number
DE0507115
Registration Date
July 27, 2022
Change Notification Approval Date
April 07, 2025
Retention Due Date
July 26, 2025
Product Owner
Short Name
ABMRC, LLC
Address
860 Blue Gentian Road, Suite 200, Eagan, MN, USA 55121, UNITED STATES
Registrant
Address
36 ROBINSON ROAD, CITY HOUSE, #20-01, SINGAPORE 068877
Importer
Address
7030 ANG MO KIO AVENUE 5, NORTHSTAR @ AMK, #04-20, SINGAPORE 569880
Model Information
Model Name(s)
BiWaze Cough BiWaze Remote Mobile Application (Android) BiWaze Remote Mobile Application (iOS) Standard Breathing Circuit with Face Mask - Infant Standard Breathing Circuit with Face Mask - Toddler Standard Breathing Circuit with Face Mask - Child/Adult Small Standard Breathing Circuit with Face Mask - Adult Medium Standard Breathing Circuit with Trach Standard Breathing Circuit with Moutpiece Standard Breathing Circuit with Face Mask - Adult Large Air Inlet Filter BiWaze Cough Dual Lumen Circuit with Mouthpiece BiWaze Cough Dual Lumen Circuit with Trach Adapter BiWaze Cough Dual Lumen Circuit with Face Mask – Child BiWaze Cough Dual Lumen Circuit with Face Mask - Adult Small BiWaze Cough Dual Lumen Circuit with Face Mask - Adult Medium BiWaze Cough Dual Lumen Circuit with Face Mask - Adult Large Foot Switch
Model Identifier(s)
2037351818-20113 BC20121 BC20122 BC21086 BC21087 BC21088 BC21089 BC21090 BC21092 BC21273 BC21274 BC23387 BC23394 BC23400 BC23406 BC23412 BC23418 FSR-21-10W-2-22/4S-PH3.5