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Flexicare HME Booster Heater System - HSA Registration DE0510064

Access comprehensive regulatory information for Flexicare HME Booster Heater System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510064 and owned by FlexiCare Medical Ltd. The device was registered on November 22, 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
DE0510064
Flexicare HME Booster Heater System
HSA Registration Number: DE0510064
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Product Description

The HME Booster Heater is used in conjunction with the Hygrovent Gold or the HME Booster T-piece to add heat and water to gases used for artificial respiration, either in the Intensive Care Unit or during anaesthesia (unless the anaesthetic mixture is flammable). The device is intended for ventilated patients who are intubated, have by-passed upper airways and who require extra heat and moisture in the inhaled gases to compensate for excessive moisture loss from the lower airways. For use by trained personnel only within a hospital environment.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0510064
Registration Date
November 22, 2024
Retention Due Date
November 21, 2025
Product Owner
Short Name
FlexiCare Medical Ltd
Address
Cynon Valley Business Park, Mountain Ash, 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)
Adult Hygrovent Gold WFL Breathing System 1.8m Kit 1 Adult Hygrovent Gold WFL Breathing System 2.4m Kit 1 Adult HME-Booster T-Piece WFL Breathing System 1.8m Kit 1 Adult HME-Booster T-Piece WFL Breathing System 2.4m Kit 1 Hygrovent Bacterial Viral HMEF Hygrovent S Bacterial Viral HMEF Small Hygrovent S Angled Bacterial Viral HMEF Small Hygrovent Child Angled Bacterial Viral HMEF Hygrovent Child Straight Bacterial Viral HMEF Hygrovent Bacterial Viral HMEF Hygrovent S Bacterial Viral HMEF Small Hygrovent S Angled Bacterial Viral HMEF Small Hygrovent Child Angled Bacterial Viral HMEF Hygrovent Child Straight Bacterial Viral HMEF HME-Booster T-piece with Hygrovent S Bacterial Viral HMEF Small HME-Booster T-Piece Kit 2 HME-Booster T-Piece Kit 1 Hygrovent Gold Basic Hygrovent Gold Comfort Hygrovent Gold Standard Hygrovent Gold Standard Flex HME booster heater 4m (UK)
Model Identifier(s)
038-04-450 038-04-451 038-04-452 038-04-453 300-100-000 300-200-000 300-210-000 300-510-000 300-520-000 301-100-000 301-200-000 301-210-000 301-510-000 301-520-000 354-200-000 354-205-010 354-215-010 355-000-000 355-001-010E 355-005-010E 355-105-015F 358 931 400