Flexicare Anesthesia Breathing Systems - HSA Registration DE0504305
Access comprehensive regulatory information for Flexicare Anesthesia 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 DE0504305 and owned by Flexicare Medical Limited. The device was registered on April 02, 2020.
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
DE0504305
Flexicare Anesthesia Breathing Systems
HSA Registration Number: DE0504305
Product Description
Flexicare® Anesthesia Breathing Systems are used for Adult, Paediatric and Infant/Neonatal patients undergoing general Anesthesia, and are intended for both ventilated and spontaneously breathing patients within hospital operating theatres, anaesthetic rooms and recovery (PACU), during emergency and standard Anesthesia practice. The user should be familiar and trained in the selection of the appropriate Anesthesia 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
Anaesthesiology
Registration Information
Registration Number
DE0504305
Registration Date
April 02, 2020
Retention Due Date
April 01, 2026
Product Owner
Short Name
Flexicare Medical Limited
Address
Cynon Valley Business Park, Mountain Ash CF45 4ER., UNITED KINGDOM
Registrant
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Model Information
Model Name(s)
Parallel Neonatal 1.6m (63") Anesthetic Circuit (038-03-110/700/150GE)
Angled Neonatal Y-Piece + CO2 Luer Lock Monitoring Port (030-622RGE)
Swivel Elbow 22M-15F/15M (010-643RGE)
Swivel Y-Connector + CO2 Luer Lock Monitoring Port 22M-15F/22M/22M (010-623LRGE)
Bag Arm Connector Reusable (010-607RGE)
Scavenging Tube 5m (197") + 2 x 30F/22M Connector (038-01-248eaGE)
Smoothbore Tube Pediatric 1.1m (43") Reusable 22F-15F (038-02-238ReaGE)
Jackson Rees 2.1m (83") Star Lumen Inspiratory Tube (038-02-198GE)
Expandable Adult 1.8m (71") Circuit + Y-Piece Luer Elbow + 3L Reservoir Bag (038-01-610UGE)
Corrugated Limb 0.9m(35") + Bag Arm Connector +1 x 22F Connector + 2L Reservoir Bag (038-01-239GE)
Parallel 1.8m (71") Circuit + Mon Line + Luer Elbow + 3L Res Bag + 1m Limb + Bag Arm (038-01-110/1GE)
Parallel 1.8m (71") Circuit + Elbow 2L Reservoir Bag + 1.5m Limb (038-01-110/2GE)
Parallel 1.6m (63") Circuit + Y-Piece + Low Profile Elbow + Luer Lock Port (038-01-100/641GE)
Straight Connector 22M/22F + Port (010-605/1GE)
Elbow 22M/15F (010-640GE)
Parallel Pediatric 1.6m (63") Circuit + Ported Y-Piece + Swivel Elbow (038-02-165AGE)
Parallel Neonatal 1.6m (63") Anesthetic Circuit (038-03-110/700/150eaGE)
Scavenging Tube 5m (197") + 2 x 30F/22M Connector (038-01-248GE)
Smoothbore Tube Pediatric 1.1m (43") Reusable 22F-15F (038-02-238RGE)
Silicone Reservoir Bag 0.5L (600 040 005eaGE)
Silicone Reservoir Bag 1L (600 040 001eaGE)
Silicone Reservoir Bag 2L (600 040 002eaGE)
Silicone Reservoir Bag 3L (600 040 003eaGE)
HMEF Child Straight Filter (303 520 000GE)
Adult Bacterial Viral Filter + Luer Port (038-41-365GE)
Adult Pleated Paper Hydrophobic Bacterial Viral Filter + Luer Port (038-41-375GE)
Mini Bacterial Viral HMEF + Luer Port (038-42-355GE)
Adult Bacterial Viral HMEF + Luer Port (038-41-355GE)
Anesthesia Face Mask Silicone Reusable Neonatal Size 0 (038-53-440SILeaGE)
Anesthesia Face Mask Pre-Filled Inflatable Single-Use Neonatal Size 0 (038-53-440GE)
Anesthesia Face Mask Pre-Filled Inflatable Single-Use Small Child Size 1 (038-52-430GE)
Anesthesia Face Mask Pre-Filled Inflatable Single-Use Medium Child Size 2 (038-52-420GE)
Anesthesia Face Mask Pre-Filled Inflatable Single-Use Large Child Size 3 (038-52-415GE)
Anesthesia Face Mask Pre-Filled Inflatable Single-Use Adult Size 4 (038-51-410GE)
Anesthesia Face Mask Pre-Filled Inflatable Single-Use Large Adult Size 5 (038-51-400GE)
Anesthesia Face Mask Pre-Filled Inflatable Single-Use Extra Large Adult Size 6 (038-51-390GE)
Anesthesia Face Mask Silicone Reusable Small Child Size 1 (038-52-430SILeaGE)
Anesthesia Face Mask Silicone Reusable Medium Child Size 2 (038-52-420SILeaGE)
Anesthesia Face Mask Silicone Reusable Large Child Size 3 (038-52-415SILeaGE)
Anesthesia Face Mask Silicone Reusable Adult Size 4 (038-51-410SILeaGE)
Anesthesia Face Mask Silicone Reusable Large Adult Size 5 (038-51-400SILeaGE)
Scavenging Bag Reusable 3L 30M/22F (038-81-835ReaGE)
Silicone Reservoir Bag 0.5L (600 040 005GE)
Silicone Reservoir Bag 1L (600 040 001GE)
Silicone Reservoir Bag 2L (600 040 002GE)
Silicone Reservoir Bag 3L (600 040 003GE)
Anesthesia Face Mask Silicone Reusable Neonatal Size 0 (038-53-440SILGE)
Anesthesia Face Mask Silicone Reusable Small Child Size 1 (038-52-430SILGE)
Anesthesia Face Mask Silicone Reusable Medium Child Size 2 (038-52-420SILGE)
Anesthesia Face Mask Silicone Reusable Large Child Size 3 (038-52-415SILGE)
Anesthesia Face Mask Silicone Reusable Adult Size 4 (038-51-410SILGE)
Anesthesia Face Mask Silicone Reusable Large Adult Size 5 (038-51-400SILGE)
Model Identifier(s)
2105488-001
2105488-002
2105488-003
2105488-004
2105488-005
2105488-006
2105488-007
2105488-008
2105488-011
2105488-012
2105488-013
2105488-014
2105488-015
2105488-016
2105488-018
2105488-020
2105488-021
2105488-022
2105488-023
2106570-001
2106570-002
2106570-003
2106570-004
2106570-006
2106570-007
2106570-008
2106570-009
2106570-010
2106570-011
2106570-012
2106570-013
2106570-014
2106570-015
2106570-016
2106570-017
2106570-018
2106570-019
2106570-020
2106570-021
2106570-022
2106570-023
2106570-024
2106570-025
2106570-026
2106570-027
2106570-028
2106570-029
2106570-030
2106570-031
2106570-032
2106570-033
2106570-034