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GE S/5™ Patient Side Module - HSA Registration DE0007846

Access comprehensive regulatory information for GE S/5™ Patient Side 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 DE0007846 and owned by GE Healthcare Finland Oy. The device was registered on November 09, 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
DE0007846
GE S/5™ Patient Side Module
HSA Registration Number: DE0007846
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Product Description

The Patient Side Module and accessories are indicated for the monitoring of hemodynamic parameters of all hospital patients. The hemodynamic parameters of the module comprise ECG including ST-segment and arrhythmia, impedance respiration (for patients aged 3 and up), NIBP (for patients who weigh 5kg and up), temperature, SpO2 (including monitoring during conditions of clinical patient motion). Impedance respiration measurement is indicated for patients aged 3 and up. The Patient Side Module (model family E-PSM(P)) is also indicated for invasive blood pressure.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
HSA Product Code
Refer to CRPNS
HS Code
90181900
Registration Information
Registration Number
DE0007846
Registration Date
November 09, 2011
Change Notification Approval Date
January 16, 2014
Retention Due Date
November 08, 2025
Product Owner
Short Name
GE Healthcare Finland Oy
Address
Kuortaneenkatu 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)
DURA-CUF, Adult Long, 2 TB, Mated Submin, Navy 23 - 33cm DURA-CUF, Large Adult Long, 2 TB, Mated Submin, Wine 31 - 40cm Temp.Ext.Cable,400-Ser,RSP/Mallin,1m Temp Extension Cable, 400-Ser, 2.8m Adult NIBP cuff hose SOFT-CUF, Child, 2 TB, Mated Submin, Green/White 12 - 19cm SOFT-CUF, Small Adult, 2 TB, Mated Submin, Lt. Blue/White 17 - 25cm SOFT-CUF, Adult, 2 TB, Mated Submin, Navy/White 23 - 33cm SOFT-CUF, Adult Long, 2 TB, Mated Submin, Navy/White 23 - 33cm SOFT-CUF, Large Adult, 2 TB, Mated Submin, Rose/White 31 - 40cm SOFT-CUF, Large Adult Long, 2 TB, Mated Submin, Rose/White 31 - 40cm SOFT-CUF, Thigh, 2 TB, Mated Submin, Brown/White 38 - 50cm SENSA-CUF Cuff, Infant, 2-Tube Screw Connector, Orange/Gray SOFT-CUF Cuff, Neonatal #3, 2-Tube Neo - Male Slip Luer, Green Duck SOFT-CUF Cuff, Neonatal #4, 2-Tube Neo - Male Slip Luer, Blue Dog SOFT-CUF Cuff, Neonatal #5, 2-Tube Neo - Male Slip Luer, Red Dinosaur CLASSIC-CUF Cuff, Neonatal #5, 2-Tube Neo - Male Slip Luer, Red Dinosaur, 8 - 15cm CLASSIC-CUF Cuff, Neonatal #4, 2-Tube Neo - Male Slip Luer, Blue Dog, 7 - 13cm CLASSIC-CUF Cuff, Neonatal #3, 2-Tube Neo - Male Slip Luer, Green Duck, 6 - 11cm CLASSIC-CUF Cuff, Infant, 2-Tube Screw Connector, Yellow DURA-CUF Cuff, Infant, 2-Tube Mated Sub-Miniature, Rust, 8 - 13cm DURA-CUF Cuff, Child, 2-Tube Mated Sub-Miniature, Green, 12 - 19cm DURA-CUF Cuff, Small Adult, 2-Tube Mated Sub-Miniature, Royal Blue, 17 - 25cm DURA-CUF Cuff, Adult, 2-Tube Mated Sub-Miniature, Navy, 23 - 33cm DURA-CUF Cuff, Large Adult, 2-Tube Mated Sub-Miniature, Wine, 31 - 40cm Infant/neonatal NIBP cuff hose 3-lead ECG set, clip, 75cm/30in, IEC 5-lead ECG set, clip, 125cm/47in,IEC 3-lead ECG set, clip, 75cm/30in,AAMI 5-lead ECG set, clip,125cm/47in,AAMI 3-lead ECG set, snap, 75cm/30in,AAMI 5-lead ECG set, snap,125cm/47in,AAMI Replacement Clip lead red R, 0.75 m/30 in. Replacement Clip lead green F, 0.75 m/30 in. Replacement Clip lead yellow L, 0.75 m/30 in. Replacement Clip lead white C, 0.75 m/30 in. Replacement Clip lead black LA, 0.75 m/30 in. Replacement Clip lead brown V, 0.75 m/30 in. Replacement Clip lead red LL, 1.25 m/49 in. Replacement Clip lead green F, 1.25 m/49 in. Replacement Clip lead black N, 1.25 m/49 in. Replacement Clip lead green RL, 1.25 m/49 in. Replacement Snap lead red LL, 0.75 m/30 in. Replacement Snap lead black LA, 0.75 m/30 in. Replacement Snap lead white RA, 0.75 m/30 in. Replacement Snap lead brown V, 0.75 m/30 in. Replacement Snap lead red LL, 1.25 m/49 in. Replacement Snap lead green RL, 1.25 m/49 in. Replacement Clip lead red LL, 0.75 m/30 in. Replacement Clip lead white RA, 0.75 m/30 in. 300-Series 3-lead Set with clips 150cm/ 60in, AAMI 300-Series 5-lead Set with clips 150cm/ 60in, AAMI 300-Series 3-lead Set with clips 150cm/60in, IEC 300-Series 5-lead Set with clips 150cm/ 60in, IEC Replacement Clip lead red LL, 1.5 m/60 in. Replacement Clip lead brown V, 1.5 m/60 in. Replacement Clip lead green RL, 1.5 m/60 in. Replacement Clip lead white RA, 1.5 m/60 in. Replacement Clip lead black LA, 1.5 m/60 in. PSM Module (Patient Side Module, non-invasive) PSMP Module (Patient Side Module) Compatibility Trunk Cable, 3-lead, from Multi-Link connector to 300 Series Leadset, IEC, 3.0 m/ 10 ft Compatibility Trunk Cable, 3-lead, from Multi-Link connector to 300 Series Leadset, AAMI/AHA, 3.0 m/ 10 ft Compatibility Trunk Cable, 5-lead, from Multi-Link connector to 300 Series Leadset, IEC, 3.0 m/ 10 ft Compatibility Trunk Cable, 5-lead, from Multi-Link connector to 300 Series Leadset, AAMI/AHA, 3.0 m/ 10 ft Esophageal stethoscope with temp probe, Disposable, 9 Fr Esophageal stethoscope with temp probe, Disposable, 12 Fr Esophageal stethoscope with temp probe, Disposable, 18 Fr Esophageal stethoscope with temp probe, Disposable, 24 Fr Skin probe, Disposable General Purpose Probe, Disposable, Pediatric, 9 Fr General Purpose Probe, Disposable, Adult, 12 Fr Tympanic Temperature Probe, Adult, 400 series, Disposable Tympanic Temperature Probe, Pediatric, 400 series, Disposable Foley Catheter w/Temperature Probe, 14 Fr, Disposable, 400 series Foley Catheter w/Temperature Probe, 16 Fr, Disposable, 400 series Foley Catheter w/Temperature Probe, 18 Fr, 400 series General Purpose Temperature Probe, 12 Fr, reusable General Purpose Temperature Probe, 9 Fr, reusable Skin Temperature Probe, reusable Pole mount for PSM, short Frame mount for PSM Pole mount for PSM, long Module bus adapter for PSM PSM Interface Module, E-INTPSM Disposable Oximeter Sensors Disposable Oximeter Sensors Disposable Oximeter Sensors Durable Oximeter Sensors and Cables Ear sensor wirh GE connector Ear sensor wirh GE connector Durable Oximeter Sensors and Cables Durable Oximeter Sensors Finger sensor with GE connector Finger sensor with GE connector Foam Replacement Wrap Small Durable Oximeter Sensors Durable Oximeter Sensors
Model Identifier(s)
0.002756 0.002757 165640 165641 2021285-001 2451 2452 2453 2454 2455 2456 2457 2458 2523 2524 2525 2619 2623 2628 2650 2750 2751 2752 2753 2754 414874-001 545315 545316 545317 545318 545327 545328 545340 545341 545342 545343 545344 545345 545346 545347 545348 545349 545350 545351 545352 545353 545354 545355 545358 545359 8001958 8001959 8001960 8001961 8003274 8003275 8003276 8003277 8003278 E-PSM-00 E-PSMP-00 M1020453 M1020454 M1020541 M1020546 M1024205 M1024212 M1024215 M1024218 M1024222 M1024229 M1024231 M1024233 M1024237 M1024239 M1024242 M1024244 M1024247 M1024251 M1024254 M1049197 M1051021 M1051023 M1051025 M1054424 OXY-AF-10 OXY-AP-10 OXY-AP-25 OXY-E-UN OXY-E2-GE OXY-E4-GE OXY-ES3 OXY-F-UN OXY-F2-GE OXY-F4-GE OXY-RWS OXY-SE-3 OXY-W-UN