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FLEXICARE VENTILATOR BREATHING SYSTEMS - HSA Registration DE0502073

Access comprehensive regulatory information for FLEXICARE VENTILATOR BREATHING SYSTEMS in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0502073 and owned by FlexiCare Medical Ltd. The device was registered on August 28, 2018.

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
DE0502073
FLEXICARE VENTILATOR BREATHING SYSTEMS
HSA Registration Number: DE0502073
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Product Description

Flexicare Ventilator Breathing Systems are used for adult, paediatric and infant/neonatal patients, and are intended for use to connect a patient’s airway to a Ventilator and Humidification Chamber as part of a complete system to provide humidified inspired respiratory gases to ventilated patients and those receiving respiratory support. The user should be familiar and trained in the selection of the appropriate breathing system, the use and the care of the product.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0502073
Registration Date
August 28, 2018
Retention Due Date
August 27, 2025
Product Owner
Short Name
FlexiCare Medical Ltd
Address
Cynon Valley Business Park, Mountain Ash, Rhondda Cynon Taff, CF45 4ER, UNITED KINGDOM
Registrant
Address
17 KAKI BUKIT PLACE, EUNOS TECHPARK, SINGAPORE 416195
Importer
Address
17 KAKI BUKIT PLACE, EUNOS TECHPARK, #---, SINGAPORE 416195
Model Information
Model Name(s)
Ventilator Breathing System Adult 1.6m Kit 1 Ventilator Breathing System Adult 2.4m Kit 1 Ventilator Breathing System Adult 1.6m with 0.8m Limb Kit 5 Ventilator Breathing System Adult 1.6m Y-Piece with 2 x Ports Kit 6 Ventilator Breathing System Adult 1.6m Y-Piece with 2 x Ports and 1 x Water Trap Kit 1 Ventilator Breathing System Adult 1.6m Y-Piece with 2 x Ports and 2 x Water Traps Kit 1 Ventilator Breathing System Adult 1.6m Y-Piece with 2xPorts 2xWater Traps + MaxiNeb Nebuliser Kit 7 Adult Single Heated Wire Breathing System 22mm 1.6m Water Trap and Auto fill Chamber Adult CPAP Single Limb Heated Wire Breathing System 22mm 1.6m Kit 2 Adult Dual Heated Wire Breathing System 22mm 1.6m Kit 1 Adult Dual Heated Wire Breathing System 22mm 1.6m Kit 2 Adult Dual Heated Wire Breathing System 22mm 1.6m Kit 3 Adult Ventimyst Dual Heated Wire Breathing System 1.6m Kit 1 Adult Ventimyst Dual Heated Wire Breathing System 1.6m Kit 2 Adult Dual Heated Wire Convertible Breathing System 22mm 1.6m Kit 1 Adult CPAP / HFOT Single Limb Heated Wire Breathing System 22mm 1.6m Kit 1 Adult CPAP / HFOT Single Limb Heated Wire Breathing System 22mm 1.6m Kit 2 Adult CPAP / HFOT Single Limb Heated Wire Breathing System 22mm 1.6m Kit 3 Adult CPAP / HFOT Shielded Single Limb Heated Wire Breathing System 22mm 1.6m Kit 1 Adult Bi-PAP Single Limb Heated Wire Breathing System 1.6m Kit 1 Adult Breathing System 22mm 1.6m Auto-Fill Chamber and Self-Sealing Water Trap Adult Breathing System 22mm 1.6m Auto-Fill Chamber and 2 x Self-Sealing Water Traps Paediatric Single Heated Wire Breathing System 1.6m Kit 1 Paediatric Dual Heated Wire Breathing System 1.6m Kit 1 Neonatal Ventimyst Dual Heated Wire B/S 1.6m (63") (Kit 1) Neonatal Ventimyst Dual Heated Wire B/S 1.6m (63") S-Type (Kit 1) Neonatal Ventimyst Dual Heated Wire B/S 1.6m (63") (Kit 2) Neonatal Ventimyst Dual Heated Wire B/S 1.6m (63") S-Type (Kit 2) Neonatal Ventimyst Dual Heated Wire B/S 1.6m (63") (Low Flow) (Kit 3) Adult Smoothbore Bi-PAP Single Limb Breathing System 1.8m with Exhalation Port Adult Bi-PAP Single Limb Breathing System 1.6m with Exhalation Port Adult Smoothbore IPPB Breathing System 1.6m with Exhalation Valve Adult Nebulising IPPB Breathing System 1.6m Exhalation Valve MaxiNeb 90 Nebuliser and Mouthpiece Adult CPAP Single Limb Breathing System 2.0m with T-Piece
Model Identifier(s)
038-01-130 038-01-132 038-01-135 038-01-140 038-01-150 038-01-155 038-01-155F 038-31-101 038-31-102 038-31-201 038-31-202 038-31-203 038-31-252 038-31-253 038-31-301 038-31-401 038-31-402 038-31-403 038-31-501 038-31-601 038-31-756 038-31-761 038-32-101 038-32-201 038-33-252 038-33-252/S 038-33-253 038-33-253/S 038-33-255 038-35-292 038-35-295 038-35-310 038-35-323 038-35-950