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Breas Medical Clearway 2 - HSA Registration DE0510148

Access comprehensive regulatory information for Breas Medical Clearway 2 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510148 and owned by Breas Medical Ltd.. The device was registered on December 16, 2024.

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 C
DE0510148
Breas Medical Clearway 2
HSA Registration Number: DE0510148
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Product Description

The Clearway 2 airway clearance device assists patients in loosening, mobilizing, and clearing secretions, as well as promoting lung volume recruitment by Mechanical Insufflation-Exsufflation (MI-E). The device can be used by adult or paediatric patients that have compromised secretion clearance and/or a reduced ability to cough effectively. The device can be used for MI-E in both invasively and non-invasively ventilated patients as well as patients who are self-ventilating. The device may be used either with a facemask, mouthpiece, or with a suitable adapter to a patientโ€™s endotracheal (ET) or tracheostomy tube (MI-E only). The device is intended for use within a hospital, institutional environment, or in the home.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0510148
Registration Date
December 16, 2024
Retention Due Date
December 15, 2025
Product Owner
Short Name
Breas Medical Ltd.
Address
Unit A2 The Bridge Business Centre, Timothyโ€™s Bridge Road, Stratford-upon-Avon, CV37 9HW, UNITED KINGDOM
Registrant
Address
37 UBI CRESCENT, SINGAPORE 408586
Importer
Address
37 UBI CRESCENT, SINGAPORE 408586
Model Information
Model Name(s)
Disposable Breathing Circuit Clearway 2 Clearway 2 Clearway 2 Clearway 2 Clearway 2
Model Identifier(s)
8276 232000 232066 232166 232266 232366