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Flexicare Flexicare Anaesthesia Breathing System - HSA Registration DE0508066

Access comprehensive regulatory information for Flexicare Flexicare Anaesthesia Breathing System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508066 and owned by Flexicare Medical Limited. The device was registered on May 04, 2023.

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
DE0508066
Flexicare Flexicare Anaesthesia Breathing System
HSA Registration Number: DE0508066
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Product Description

Flexicare Anaesthesia Breathing Systems are used for Adult, Paediatric and Infant/Neonatal patients undergoing general anaesthesia, and are intended for both ventilated and spontaneously breathing patients within hospital operating theatres, anaesthetic rooms and recovery (PACU), during emergency and standard anaesthesia practice. The user should be familiar and trained in the selection of the appropriate Anaesthesia Breathing System, the use and the care of the product, and should be aware of any clinical contraindications.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0508066
Registration Date
May 04, 2023
Retention Due Date
May 03, 2026
Product Owner
Short Name
Flexicare Medical Limited
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)
Mouthpiece For Oxygen / Nitrous Oxide Circuit Parallel Circuit 1.6m 22mm with Y-Piece Argentic Parallel Circuit 1.6m 22mm with Y-Piece Parallel Circuit 1.6m 22mm Tube with Swivel Y-Piece Parallel Circuit 2.4m 22mm Tube with Swivel Y-Piece Parallel Circuit 2.4m 22mm with Y-Piece Parallel Circuit 1.6m 22mm with Y-Piece 0.8m Limb Low Profile Elbow and 2L Res Bag Parallel Circuit 1.6m 22mm with Y-Piece 0.8m Limb Elbow 3m Monitoring Line and 2L Res Bag Argentic Parallel Circuit 1.6m 22mm with Y-Piece 0.8m Limb Elbow and 2L Res Bag Parallel Circuit 1.6m Custom Kit A For GE Avance Aisys and Aespire Carestation with ABS Parallel Circuit 2.4m 22mm with Y-Piece 0.8m Limb Low Profile Elbow and 2L Res Bag Parallel Circuit 2.4m Custom Kit B For GE Avance Aisys and Aespire Carestation with ABS Parallel Circuit 4.5m 22mm with Y-Piece 1.6m Limb and 2L Res Bag Parallel Circuit 1.6m 22mm with Y-Piece and 0.8m Limb Argentic Parallel Circuit 1.6m 22mm with Y-Piece and 0.8m Limb Parallel Circuit 2.4m 22mm with Y-Piece and0.7m Limb Argentic Parallel Circuit 2.4m 22mm with Y-Piece and 0.8m Limb Oxygen / Nitrous Oxide Circuit 2.4m 22mm Tube One Way Valve Detachable Scavenging Tube 22mm F Oxygen / Nitrous Oxide Circuit 2.4m 22mm Tube with Mouthpiece One Way Valve and 22mm F Oxygen / Nitrous Oxide Circuit 2.4m 22mm Tube with Face Mask One Way Valve and 22mm F Oxygen / Nitrous Oxide Circuit 2.4m 22mm Tube with Mouthpiece Face Mask One Way Valve and 22mm F Bain Coaxial System 1.6m 22mm with 22mm M Swivel Connector and Elbow Bain Coaxial System 1.6m 22mm Custom Kit B Argentic Bain Coaxial System 1.6m 22mm Lightweight Tube Custom Kit B Bain Coaxial System 2.4m 22mm with 22mm M Swivel Connector and Elbow Argentic Bain Coaxial System 2.4m 22mm Custom Kit A Mapleson D Adult Bain System 1.6m 22mm with 2L Res Bag and APL Valve Argentic Mapleson D Adult Bain System 1.6m 22mm with 2L Res Bag and APL Valve Mapleson D Adult Bain System 2.4m 22mm with 2L Res Bag and APL Valve Mapleson D Adult Bain System 5.4m 22mm with 2L Res Bag and APL Valve Argentic Mapleson D Adult Bain System 5.4m 22mm with 2L Res Bag and APL Valve Mapleson C Adult Bagging System 1.6m 10mm Tubing with 2L Res Bag + APL Valve + 15F/6-9mm F Connecto Mapleson A Adult Magill System 1.6m 22mm with 2L Res Bag and APL Valve Argentic Mapleson A Adult Magill System 1.6m 22mm with 2L Res Bag and APL Valve Mapleson A Adult Parallel Lack 1.6m 22mm with 2L Res Bag and APL Valve Argentic Mapleson A Adult Parallel Lack 1.6m 22mm with 2L Res Bag and APL Valve Mapleson C Adult Bagging System 2.1m Star Lumen Tube with 2L Res Bag + APL Valve and 22mm F Adaptor Mapleson C Adult Bagging System 4m Star Lumen Tube with 2L Res Bag + APL Valve and 22mm F Adaptor Ventiflow Coaxial Circuit 1.6m Argentic Ventiflow Coaxial Circuit 1.6m Ventiflow Basic Coaxial Circuit 1.6m Argentic Ventiflow Basic Coaxial Circuit 1.6m Ventiflow Basic Coaxial Circuit 2.4m System W/Flexilock Limb Argentic Ventiflow Coaxial Circuit 2.4m Ventiflow Basic Coaxial Circuit 2.4m Argentic Ventiflow Basic Coaxial Circuit 2.4m Ventiflow Basic Circuit 1.6m System with Monitoring Line & Flexi-Lock Limb Argentic Ventiflow Standard Coaxial Circuit 1.6m Ventiflow Standard Coaxial Circuit 2.4m Argentic Ventiflow Standard Coaxial Circuit 2.4m Ventiflow Plus Coaxial Circuit 1.6m Argentic Ventiflow Plus Coaxial Circuit 1.6m Ventiflow Plus Coaxial Circuit 2.4m Argentic Ventiflow Plus Coaxial Circuit 2.4m Ventiflow Max Coaxial Circuit 1.6m Argentic Ventiflow Max Coaxial Circuit 1.6m Ventiflow Max Coaxial Circuit 2.4m Argentic Ventiflow Max Coaxial Circuit 2.4m Paediatric Parallel Circuit 1.6m with Y-Piece 22mm F Connectors and 22mm M/M Connector Mapleson F Infant T-Piece 1.6m 10mm Corrugated Inspiratory Tube Mapleson F Ayres T-Piece 2.1m Star Lumen Inspiratory Tube Kit 11 Mapleson F Ayres T-Piece 1.6m 10mm Corrugated Inspiratory Tube Kit 1 Mapleson F Ayres T-Piece 2.1m Star Lumen Inspiratory Tube Kit 13 Mapleson C Paediatric Direct System 1.6m 10mm with 1L Res Bag APL and 15F/6-9mm F Connector Mapleson C Paediatric Bagging System 1.6m 10mm with 0.5L Res Bag APL Valve and 15F/6-9mm F Connector Mapleson C Paediatric Direct System 1.6m 10mm with 1L Res Bag APL Valve and 15F/6-9mm F Connector Mapleson F Ayres T-Piece 1.6m 10mm Corrugated Inspiratory Tube Kit 5 Neonatal Parallel Circuit 4.0m 10mm Y-Piece with Suction Valve and 22mm F Connectors Neonatal Parallel Circuit 1.6m 10mm Y-Piece with Suction Valve and 22mm F Connectors Neonatal Circuit 1.6m 10mm Y-Piece with Suction Valve + 22mm F Connectors + 1.6m Limb 0.5L Res Bag Oxygen / Nitrous Oxide Circuit Mouthpiece with ThermoShield Bacterial Viral HME Filter
Model Identifier(s)
032-10-066 038-01-100 038-01-100Ag 038-01-102 038-01-103 038-01-105 038-01-110 038-01-110/701 038-01-110Ag 038-01-110GE 038-01-110LX 038-01-110LXGE 038-01-110LXXY 038-01-120 038-01-120Ag 038-01-125 038-01-125Ag 038-01-173 038-01-176 038-01-177 038-01-178 038-01-200 038-01-200B 038-01-200BAg 038-01-210 038-01-210Ag 038-01-251 038-01-251Ag 038-01-253 038-01-254 038-01-254Ag 038-01-255 038-01-256 038-01-256Ag 038-01-257 038-01-257Ag 038-01-258 038-01-258A 038-01-500 038-01-500Ag 038-01-501 038-01-501Ag 038-01-505 038-01-505Ag 038-01-506 038-01-506Ag 038-01-510 038-01-510Ag 038-01-515 038-01-515Ag 038-01-520 038-01-520Ag 038-01-525 038-01-525Ag 038-01-530 038-01-530Ag 038-01-535 038-01-535Ag 038-02-165 038-02-191 038-02-195 038-02-196 038-02-198 038-02-270 038-02-271 038-02-272 038-02-273 038-03-110/2 038-03-110/3 038-03-110B 038-41-369