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GE Healthcare Compact Airway Module - HSA Registration DE0005898

Access comprehensive regulatory information for GE Healthcare Compact Airway Module in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0005898 and owned by GE Finland Oy. The device was registered on January 03, 2011.

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
DE0005898
GE Healthcare Compact Airway Module
HSA Registration Number: DE0005898
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Product Description

The Compact Airway Module, E-CAIOVX family (E-CaiO, E-CaiOV, E-CAiOVX, E-CO, E-COV and E-COVX) is indicated for monitoring hospital patients respiration (CO2, 02, N20, anesthetic agent Identification and respiration rate) ventilation (airway pressure, volume and flow) and gas exchange status (Oxygen Consumption VO2, Carbon Dioxide production VCO2, Respiratory Quotient RQ, and Energy Expenditure, EE). Gas exchange status monitoring is not indicated in the presence of N20+02 mixtures.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Anaesthesiology
HSA Product Code
Refer to CRPNS
HS Code
90181900
Registration Information
Registration Number
DE0005898
Registration Date
January 03, 2011
Change Notification Approval Date
April 14, 2017
Retention Due Date
January 02, 2026
Product Owner
Short Name
GE Finland Oy
Address
Kourtaneenkatu 2, FI-00510 Helsinki, FINLAND
Registrant
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
Address
2 Kallang Avene, CT Hub, #05-04, SINGAPORE 339407 11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253
Model Information
Model Name(s)
Gas Sampling Line, disposable, PVC/PE, 2m/7ft Gas Sampling Line, disposable, PVC/PE, 3m/10ft Gas Sampling Line, disposable, PVC/PE, 6m/20ft Sampling line, 6m, M/M Luer, 5 pcs CO2 Sampling line, 2m,M/M luer,10pcs CO2 Sampling line, 3m,M/M luer,10pcs Sampling line, male/male elbow,10pcs Sampling line, 2m, M/M Luer, 10pcs Sampling line, 2m, M/M Luer, 100 pcs Sampling line, 3m M/M Luer,10 pcs Sampling line, 3m, M/M Luer, 100 pcs Straight T-adapter, disposable 10pcs Straight T-adapter, 100 pcs Elbow adapter, disposable, 10 pcs PN-CONN, CONNECTOR-TUBE,T-ADAPTER, ELBOW.M&F 15mm, M 22mm, DISPOSABLE, 100pcs D-lite sensor, reusable Pedi-lite sensor, reusable D-lite sensor, disposable, 50 pcs Pediatric adapter, 4.5 mm, pkg of 10 pcs Pediatric adapter, 5.0 mm, pkg of 10 pcs Low dead space adapter, 2.5mm, pkg of 10 pcs Low dead space adapter, 3.0mm, pkg of 10 pcs Low dead space adapter, 3.5mm, pkg of 10 pcs Pediatric adapter, 4.0mm, pkg of 10 pcs Pedi lite+ spirometry sensor, dispo, humid condit. Pediatric Spirometry Kit, pkg of 50 pcs Spirometry Kit for humid conditions, 2m, 20 pcs Spirometry Kit for humid conditions, 3m, 20 pcs Anesthesia gas sampling line 2m, elbow con. pkg 10 EXHAUST LINE WITH COLDER FITTING, 1.0m/41in, DISPOSABLE, PKG OF 1 PCS EXHAUST LINE WITH COLDER FITTING, 18 cm/7in, DISPOSABLE, PKG OF 1 PCS D-FEND Water trap, 10 pcs Nasal sampl.line,Paediatric,2m,10pcs Nasal sampl.line, Adult, 2m, 10pcs Nasal sampl.line, L-Adult, 2m, 10pcs D-FEND+ Water trap, 10pcs Spirometry tube, 3m/10ft,yellow,5pcs Spirometry Accessory Kit, 50 pcs Spirometry tube, 2m/7ft, yellow,5pcs Spirometry tube, 6m/20ft,yellow,5pcs Female/female Luer connector - Note: use to join sampling lines together, maximum length of line 9 m/29 ft. Spirometry kit patient spirometry kit for ICU D-lite+ sensor, pkg of 50 pcs E-CAiOVX-00 E-CO E-COV E-COVX E-CaiO E-CaiOV Adapter for Gas Return, disposable Exhaust line for Gas Return or Scavenging Pediatric spirometry kit, 3m, disposable Anesthesia gas sampling line, multipatient disposable, material: PVC/PE, 2 m/7 ft, pkg of 10 pcs Anesthesia gas sampling line, multipatient disposable, material: PVC/PE, 3 m/10 ft, pkg of 10 pcs Anesthesia gas sampling line, multipatient disposable, material: PVC/PE, 6 m/20 ft, pkg of 5 pcs Anesthesia gas sampling line with elbow connector, multipatient disposable, material: PVC/PE, 3 m/10 ft, pkg of 10 pcs Anesthesia gas sampling line with elbow connector, multipatient disposable, material: PVC/PE, 2 m/7 ft, pkg of 10 pcs CO2 sampling line, multipatient disposable, material: PVC, 2 m/7 ft, pkg of 10 pcs CO2 sampling line, multipatient disposable, material: PVC, 3 m/10 ft pkg of 10 pcs
Model Identifier(s)
2097307-001 2097307-002 2097307-003 73306 733162 733163 733170 73318 733188 73319 733199 73385 733856 73386 733866 733910 73393 733950 8000062 8000063 8001540 8001541 8001542 8001543 8001948 8002718 8004381 8004382 8004383 8004462 8004463 876446 878033 878034 878035 881319 884101 889560 890031 891191 893009 894255 896952 E-CAiOVX-00 E-CO-00 E-COV-00 E-COVX-00 E-CaiO-00 E-CaiOV-00 M1031273 M1031274 M1032634 M1145069 M1145070 M1145071 M1145072 M1145073 M1145075 M1145076