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Datex-Ohmeda S/5 FM Monitor System - HSA Registration DE0006386

Access comprehensive regulatory information for Datex-Ohmeda S/5 FM Monitor 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 DE0006386 and owned by GE Finland Oy. The device was registered on March 22, 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
DE0006386
Datex-Ohmeda S/5 FM Monitor System
HSA Registration Number: DE0006386
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Product Description

is indicated for monitoring of hemodynamics and respiratory status of all hospital patients

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
HSA Product Code
Refer to CRPNS
HS Code
90181900
Registration Information
Registration Number
DE0006386
Registration Date
March 22, 2011
Retention Due Date
March 21, 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
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)
CO2 Sampling line, 2m,M/M luer,10pcs CO2 Sampling line, 3m,M/M luer,10pcs 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 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 Mini D-fend water trap 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 container Nasal sampl.line,Paediatric,2m,10pcs Nasal sampl.line, Adult, 2m, 10pcs Nasal sampl.line, L-Adult, 2m, 10pcs Female/female Luer connector - Note: use to join sampling lines together, maximum length of line 9 m/29 ft. Frame for Datex-Ohmeda S/5TM FM WLAN option Critical Care Software License for FM Critical Care Software License for FM w/ Extended Arrhythmia Analysis Critical Care Service Software License for FM w/ Extended Arrhythmia Analysis Critical Care Service Software License for FM Adapter for Gas Return, disposable Exhaust line for Gas Return or Scavenging Airway Straight T Adapter, Disposable, pkg of 10 pcs, UK version Airway Elbow Adapter, Disposable, pkg of 10 pcs, UK version 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 Extension Module for FM, with CO2 Recorder module with CO2 Service licence for WLAN option Recorder module Wireless network upgrade for FM monitor
Model Identifier(s)
733162 733163 73385 733856 73386 733866 8000062 8000063 8001540 8001541 8001542 8001543 8002174 8004462 8004463 876107 878033 878034 878035 893009 F-FM-00. F-FMW-00 L-FICU04..00. L-FICU04A..00. L-FICU04AS..00. L-FICU04S..00. M1031273 M1031274 M1145066 M1145067 M1145075 M1145076 N-FC-00 N-FCREC-00 N-FMWS N-FREC-00 U-FMW