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Maquet Getinge Flow-c Anesthesia System - HSA Registration DE0506022

Access comprehensive regulatory information for Maquet Getinge Flow-c Anesthesia 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 DE0506022 and owned by Maquet Critical Care AB. The device was registered on July 29, 2021.

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
DE0506022
Maquet Getinge Flow-c Anesthesia System
HSA Registration Number: DE0506022
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Product Description

The Flow-c anesthesia system is intended for use in administering anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe. The system is intended for use by healthcare professionals, trained in the administration of anesthesia. The system is intended for use on neonate to adult patient populations. The system is intended for use in hospital environments, except MRI environments. When not in operation, the system is designed for in-hospital transport.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Anaesthesiology
Registration Information
Registration Number
DE0506022
Registration Date
July 29, 2021
Retention Due Date
July 28, 2025
Product Owner
Short Name
Maquet Critical Care AB
Address
Rontgenvagen 2, Solna, SE, 171 54, SWEDEN
Registrant
Address
20 BENDEMEER ROAD, #06-01/02, SINGAPORE 339914
Importer
Address
20 BENDEMEER ROAD, CyberHub Building, #06-02, SINGAPORE 339914 20 BENDEMEER ROAD, #06-01/02, SINGAPORE 339914
Model Information
Model Name(s)
Tube joint/adapter 22 mm Servo Duo Guard viral/bacterial filter, 60 pcs/pkg CO2 absorber (disposable), 12 pcs/pkg Extra Patient cassette Software option AFGO (AdditionalFresh Gas Outlet) Maquet filling adapter tube for Isoflurane bottle Maquet filling adapter tube for Sevoflurane bottle SIMV Pressure Support (PS) with backup PRVC Breathing circuit, 22 mm, Hytrel (1.5 m) Breathing circuit, 15 mm, Hytrel (1.5 m) Breathing circuit, 10 mm, Hytrel (1.5 m) Breathing bag set 22 mm, Hytrel Breathing bag set 10 mm, Hytrel Breathing bag set 15 mm, Hytrel Breathing bag, reusable 0.5L Breathing bag, reusable, 1L Breathing bag, reusable, 2L Breathing bag, reusable, 3L Set of breathing circuit, 22 mm, Disposable (1.5 m), 20 pcs/pkg Set of breathing circuit, 15 mm, Disposable (1.2 m), 20 pcs/pkg Set of breathing circuit, 10 mm, Disposable (1.2 m), 20 pcs/pkg Breathing bag, disposable, 20 pcs/pkg, 0.5L Breathing bag, disposable, 20 pcs/pkg, 1L Breathing bag, disposable, 20 pcs/pkg, 2L Breathing bag, disposable, 20 pcs/pkg, 3L Anesthesia mask, reusable, 10 pcs/pkg, Size 1, medium infant Anesthesia mask, reusable, 10 pcs/pkg, Size 2,, large infant Anesthesia mask, reusable, 10 pcs/pkg, Size 3, small adult Anesthesia mask, reusable, 10 pcs/pkg, Size 4, medium adult Anesthesia mask, reusable, 10 pcs/pkg, Size 5, large adult Reusable CO2 absorber Dust filter for reusable CO2 absorber, 40 pcs/pkg Vaporizer Sevoflurane, Maquet filling Vaporizer Sevoflurane, Quik Fil Vaporizer Isoflurane, Maquet filling Vaporizer Desflurane, Safe-Fil Gas sampling line, 2.5 m, 25 pcs/pkg Gas sampling line, 3.5 m, 20 pcs/pkg Gas sampling line, 4.5 m, 20 pcs/pkg Hydrophobic bacterial filter, 5 pcs Flow-c Agent usage High performance ventilation Low VT ventilation Predicted Body Weight (PBW) HLM/CPB (’Heart Lung Machine’/ CardioPulmonary Bypass mode) Insp hold/Exp hold AFGO adapter kit, on-site upgrade Pressure Control (PC) Upgrade via E-delivery, Flow-c/e Upgrade via freight, Flow-c/e Water Trap Dryline 1, 10 pcs/pkg USB SW version 04.07.01 (Flow-c) Tube connector 22-15 mm, angled, 5 pcs/pkg
Model Identifier(s)
6425581 6671775 6677845 6680325 6681887 6682290 6682292 6688197 6688200 6688202 6692180 6692182 6692185 6692187 6692190 6692192 6692195 6692197 6692200 6692202 6692205 6692207 6692210 6692215 6692217 6692220 6692222 6692227 6692230 6692232 6692235 6692237 6692582 6880430 6886601 6886611 6886621 6886631 6887042 6887043 6887044 6887498 6887700 6887888 6887889 6887892 6887893 6887895 6887896 6887999 6888006 6888359 6888360 6889352 6890200 9037730