Pure Global

Maquet Getinge FLOW-i Anesthesia System - HSA Registration DE0009135

Access comprehensive regulatory information for Maquet Getinge FLOW-i 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 DE0009135 and owned by Maquet Critical Care AB. The device was registered on April 24, 2012.

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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS C
DE0009135
Maquet Getinge FLOW-i Anesthesia System
HSA Registration Number: DE0009135
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The system is intended for use in administrating 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.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Anaesthesiology
Registration Information
Registration Number
DE0009135
Registration Date
April 24, 2012
Change Notification Approval Date
December 01, 2023
Retention Due Date
April 23, 2026
Product Owner
Short Name
Maquet
Address
Rontgenvagen 2, Solna, SE, 17195, 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)
Hydrofobic bacterial/ viral filter Test Lung 190 Clamp, rail 10x25 mm Clamp, rail 10x30 mm Connection tube 22 int. diam, (disposable), 50m Air filter nipples, for 6 mm hose, 2 pcs SERVO Humidifier 161, 100 pcs Servo Humidifier 162, 100 pcs Servo Humidifier 163, with flex tube, 100 pcs Servo Filter Humidifier 172, 100 pcs Servo Filter Humidifier, 173, with flex tube, 100 pcs Tube joint/ adapter 22 mm (22 mm out. Diam., 15 mm int. diam.) Dryline A water trap, 10 pcs Main power cable, 3.5 m Gas Hose Air, NIST female/ female (black/white), 1.5m Gas Hose Air, NIST female/ female (black/white), 5m Gas Hose O2, NIST female/ female (white), 3m Gas Hose N2O, NIST female/ female (blue), 3m Gas Hose O2, NIST female/ female (white), 5m Gas Hose N2O, NIST female/ female (blue), 5m SERVO DuoGuard viral/ bacterial filter, 60 pcs 30 mm out. Diam. ISO taper connection FLOW-i C20 FLOW-i C30 FLOW-i C40 CO2 Absorber (disposable), 12 pcs Left side DIN rail (10x25 mm) Right side DIN rail (10x25 mm) Left side Duoflex rail (10x30 mm) Right side Duoflex rail (10x30 mm) 12.7 mm/ 1/2" in hose Barb connector 25 mm/ 1" Barb Connector AGA EVAC connector DISS EVAC connector Back up gas trolley 1 x O2 + 1 x Air Auxiliary O2 and suction module Back up gas trolley 1 x O2 + 1 x N2O 3pcs. Extra mains power outlets, IEC,230V Patient cassette complete, extra Volume reflector, extra, incl. reflector socket Manual breathing bag support arm Optional module, Additional Fresh Gas Outlet (AFGO) Gas Outlets, O2 and Air, NIST Angled adaptor for sterile water container Rear handle Cleaning adapter kit Breathing bag set (Hytrel) adult, 60cm Breathing bag set (Hytrel) infant, 60 cm Set of patient tubes (Hytrel) adult, 22 mm Set of patient tubes (Hytrel)pediatric, 22/15 mm Set of patient tubes (Hytrel) infant, 10 mm Gas hose kit for auxiliary suction module O2 + Air, NIST/ISO Vaporizer Isoflurance, MAQUET filling Vaporizer Sevoflurane, MAQUET filling (Abbott, Baxter) Vaporizer Sevoflurane, QUIK FIL Vaporizer Desflurane, Saf-T-Fil MAQUET filling adapter tube for isoflurane bottle MAQUET filling adapter tube for sevoflurane bottle (Abbott, Baxter) Without Exra Mains power outlets, 230V Hose O2 Gas backup Hose Air, gas backup Hose N2O gas backup Additional Arm Adapter Kit Back up gas holder1 x N2O AFGO adapter kit FLOW-i AFGO adapter kit, on-site Upgrade via freight, FLOW-i Cable Support Arm Upgrade via e-delivery, FLOW-i Extended Ventilation Package Vertical rail converter Breathing circuit 22 mm Reusable Hytrel, 1.5m Insp. Limb Breathing circuit, 15 mm Reusable Hytrel, 1.5m Insp. Limb Breathing circuit 10 mm, Reusable Hytrel, 1.5m Insp. Limb Breathing bag set Anesthesia 22 mm Reusable Hytrel, 1.1m Insp. Limb Breathing bag set Anesthesia 10 mm Reusable Hytrel, 1.1m Insp. Limb Breathing bag set Anesthesia 15 mm Reusable Hytrel, 1.1m Insp. Limb Breathing bag Anesthesia Reusable 0.5L Breathing bag Anesthesia Reusable 1L Breathing bag Anesthesia Reusable 2L Breathing bag Anesthesia Reusable 3L Breathing circuit 22 mm Reusable Hytrel, 1.5m Insp. Limb Set of Breathing Circuit Anesthesia, 15 mm Disposable, 1.2m Insp. Limb Set of Breathing Circuit Anesthesia, 10 mm Disposable, 1.2m Insp. Limb Sampling line, 2.0 m, 25 pcs Breathing bag Anesthesia, Disposable, Size 0.5 L Breathing bag Anesthesia, Disposable, Size 1 L Breathing bag Anesthesia, Disposable Size 2L Breathing bag Anesthesia, Disposable Size 3L Anesthesia Mask Reusable, Size 0, Small Infant Anesthesia Mask Reusable, Size 1, Medium Infant Anesthesia Mask Reusable, Size 2, Large Infant Anesthesia mask Reusable, Size 3, Small Adult Anesthesia Mask Reusable, Size 4, Medium Adult Anesthesia Mask Reusable, Size 5, Large adult Anesthesia Mask, Disposable Small Adult, Size 3 Anesthesia Mask, Disposable Medium Adult, Size 4 Anesthesia Mask, Disposable Large Adult, Size 5 Anesthesia Mask, Disposable Extra Large, Size 6 CO2 absorber Reusable Back up gas holder 1 x O2 22 mm out. diam. Connector WAGD-to-vacuum connector Starter Kit Anesthesia Infant FLOW-i Remote Services Adapter Starter Kit Anesthesia Adult Gas Hose O2, NIST female/ female (white), 3m Vaporizer holder EVAC retrictor Manual breathing bag suport arm, rigid Vaporizer slot cover Dust filter for reusable CO2 reusable, 40 pcs Back up gas rack O2/N2O Backup gas rack O2/Air Msync, with holder for rail Vaporizer Isoflurane, Maquet filling Vaporizer Desflurane, Safe-Fil Gas sampling line 2.5 m, 25 pcs/pkg Gas sampling line 3.5 m, 25 pcs/pkg Gas sampling line 4.5 m, 20 pcs/pkg Vaporizer Sevoflurane, SAFE-T-SEAL Bacteria Filter (5 pcs) CO2 Absorber disposable Breathing tube water trap 22mm disp. 20pcs Breathing bag set 22 mm, disp. 20pcs Volume reflector, PEI Flow-i C20 Flow-i C30 Flow-i C40 Extra Volume reflector Water Trap Dryline 1, 10 pcs/pkg Tube connector 22-15 mm, angled, 5 pcs/pkg Air filter (shock protected), with mount bracket, without nipples Air filter nipples, for 8 mm hose, 2 pcs Clamp, 1 slot Hook with hook holder Connection cone 30 mm int./22mm out. Diam (disposable), 6 pcs.
Model Identifier(s)
57500630 6006832 6038801 6038819 6189646 6350990 6419340 6419357 6419365 6419373 6419381 6425581 6522747 6670310 6671157 6671160 6671252 6671255 6671257 6671260 6671775 6673980 6677200 6677300 6677400 6677845 6678570 6678572 6679537 6679542 6679627 6679630 6679645 6679647 6679842 6679847 6680165 6680180 6680325 6680327 6680597 6681887 6681890 6681900 6681907 6681910 6682130 6682135 6682147 6682150 6682152 6682172 6682280 6682282 6682285 6682287 6682290 6682292 6682297 6683602 6683605 6683607 6686225 6686585 6686587 6686857 6686860 6686900 6687487 6687590 6688205 6689740 6692180 6692182 6692185 6692187 6692190 6692192 6692195 6692197 6692200 6692202 6692205 6692207 6692210 6692212 6692215 6692217 6692220 6692222 6692225 6692227 6692230 6692232 6692235 6692237 6692240 6692242 6692245 6692247 6692582 6692630 6692740 6692742 6696712 6696757 6696810 6771252 6880155 6880156 6880157 6880158 6880430 6881266 6881267 6881603 6886621 6886631 6887042 6887043 6887044 6887135 6887498 6887738 6887797 6887798 6887831 6888520 6888530 6888540 6888985 6889352 9037730 9085556 9085564 9358193 9368952 9377896