Singapore HSA registration DE0006454

Datex-Ohmeda S/5™ MRI Monitor

Singapore·CLASS C·GE Finland Oy·Registered March 31, 2011

Device classification

Device Class: CLASS C
Medical Speciality Area: Anaesthesiology
HSA Product Code: Refer to CRPNS
HS Code: 90181900

Registration information

Registration Number: DE0006454
Registration Date: March 31, 2011
Retention Due Date: March 30, 2026

Product description

The MRI Monitor with L-CANE05 or L-CANE05A software, module options E-MRIPSN, E-MRICAiOV, E-MRICAiO, E-MRICO & accessories is indicated for monitoring of hemodynamic (comprising ECG (including heart rate, ST-segment and arrhythmia), NIBP, SpO2, & invasive blood pressure), respiratory (CO2, O2, N2O, anesthetic agents, anesthetic agent identification, & respiration rate), & ventilatory (comprising airway pressure, volume & flow) status of hosp patients during MR scanning. The NIBP measurement is indicated for patients who weigh 5kg & up. The MRI Monitor with L-CANE05 or L-CANE05A software is also indicated for documenting patient care related information. The MRI Monitor with L-CANE05 or L-CANE05A software, module options E-MRIPSN, E-MRICAiOV, E-MRICAiO, E-MRICO & accessories is indicated for use in the MR environment up to 300 Gauss with static magnets up to 3.0 Tesla. SpO2 and ECG monitoring is indicated only with accessories specifically designed for the MR environment.

Product Owner

Name: GE Finland Oy
Short Name: GE Finland Oy
Address: Kourtaneenkatu 2, FI-00510 Helsinki, FINLAND

Registrant

Name: GE HEALTHCARE PTE. LTD.
Address: 11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589

Importer

Name: GE HEALTHCARE PTE. LTD. GE PACIFIC HOLDINGS PTE. LTD. GE PACIFIC PRIVATE LIMITED
Address: 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): Frame Holder for S/5 Command Bar Table Holder for S/5 Command Bar Board Extension Frame (F-EXT4-03-1) S/5 Interface module S/5 Memory module S/5 Recorder Module S/5 MRI Monitor S/5 Command Bar S/5 Blank bar deioRecorder for Anesthesia S/5 anesthesia software for MRI S/5 anesthesia software for MRI Display 12" LCD Cable between F-CU5 & F-CPU, 0,3 m/ 12 in Cable between F-CU5 & F-CPU, 3 m/ 10 ft Cable between F-CU5 & F-CPU, 10 m/ 33 in Cable between F-CPU & N-AC, 0,4 m/ 16 in Cable between F-CPU & N-AC, 2,7 m/ 9 ft Holder for S/5 Command bar S/5 F-CPU table holder Adapter Plate for S/5 F-CU5(P) Power Adapter Mount Display Controller (B-DISPX-01) S/5 Anesthesia Software License (L-ANE07-00) S/5 Anesthesia Software License with extended arrhythmia analysis (L-ANE07A-00) S/5 8-Module frame (F-CU8-12-VG1) S/5 Central Processor Unit for FCU5 (F-CPU-02) S/5 5-Module frame (F-CU5P-01) S/5 5-Module frame (F-CU5-01) S/5 FCU5 power unit Shield for S/5 MRI Monitor
Model Identifier(s): 8001952 8001953 B-UPI4NET-02 E-EXT-00 E-INT-00 E-MEM-00-EN E-REC-00-EN F-MRICM1-00 K-ANEB-00-EN K-BLANKB-00 L-ARK-00-EN L-CANE05 L-CANE05A L-LCC12A-01-EN M1021337 M1021338 M1021339 M1021340 M1021341 M1027908 M1027910 M1027911 M1035232 M1076677 M1119898 M1119983 M1138441 M1138450 M1152117 M1152119 N-AC-00 N-MR12

About this record

Access comprehensive regulatory information for Datex-Ohmeda S/5™ MRI Monitor in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0006454 and owned by GE Finland Oy. The device was registered on March 31, 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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