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GE SpecialsLab Recording System - HSA Registration DE0013634

Access comprehensive regulatory information for GE SpecialsLab Recording 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 DE0013634 and owned by GE Medical Systems Information Technologies, Inc.. The device was registered on August 19, 2013.

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
DE0013634
GE SpecialsLab Recording System
HSA Registration Number: DE0013634
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Product Description

Intended for acquiring, filtering, digitizing, amplifying, measuring and calculating, displaying, recording and monitoring of clinical data from adult and pediatric patients. Clinical data includes: ECG waveforms, heart rate, pulse oximetry (SpO2), respiration rate, CO2 (EtCO2), temperature, hemodynamic measures (for example, valve gradients and areas, cardiac output, shunts, invasive and noninvasive blood pressure).

Device Classification
Device Class
CLASS C
Medical Speciality Area
Cardiovascular
HSA Product Code
HSAMDC00104
HS Code
90181100
Registration Information
Registration Number
DE0013634
Registration Date
August 19, 2013
Change Notification Approval Date
January 31, 2017
Retention Due Date
August 18, 2025
Product Owner
Short Name
GE Medical Systems
Address
8200 W. Tower Ave., Milwaukee, WI, UNITED STATES
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)
Leadwire Set, ECG, Prucka CardioLab, Grab, IEC, 94cm, 10/set Leadwire Set, ECG, Prucka CardioLab, Grab/Radiotranslucent, 36 in. AHA, 5/set Leadwire Set, ECG, Prucka CardioLab, Grab/Radiotranslucent, AHA, 72in. 180 cm, 10/set Leadwire Set, ECG, Prucka CardioLab, Grabber, AHA,72 in.180 cm, 10/set Leadwire Set, ECG, Prucka CardioLab, Grab/Radiotranslucent, IEC, 180 cm, 10/set DISK DVD-RAM CARTRIDGE 9.4 GB FORMATTED MAC-LAB ENGLISH LANGUAGE KEYBOARD COMBOLAB ENGLISH LANGUAGE KEYBOARD GE BEDSIDE MONITOR INTERFACE CABLES ANALOG OUT 16 CHANNELS ETCO2 INTERFACE ONLY 3RD PARTY XRAY INTERFACE DCIOM ONLY ADT DICOM MWL 3RD PARTY CA1000 DICOM VIEWER SOFTWARE LICENSE BARCODE SCANNER Centricity Cardiology INW Server MLCL PDM MASIMO SPO2 ENGLISH 60HZ MLCL PDM MASIMO SPO2 ENGLISH 50HZ MLCL PDM NELLCOR SPO2 ENGLISH 60HZ MLCL PDM NELLCOR SPO2 ENGLISH 50HZ WAVEFORM DATA PIPE MEDIA EXTERNAL BLU RAY KIT REMOTE SPEAKER KIT CAPNO MDL ADPTR CO2 MDL SNSR SD CARD KIT PDM BASE STATION WITH RAIL, POLE AND INTEGRATED MOUNT IEB 240V COMBOLAB 20 INCH FP MONITOR 20 INCH LCD FLAT PANEL MONITOR WITH BOOM MOUNT TWO 20 INCH LCD MONITORS THREE 20 INCH LCD MONITORS DESK 65 INCHES DESK 47 INCHES DESK CART DESK PRE OP POST OP STAND MLCL PRINTER INTERFACE KIT SINGAPORE POWER CORD 6.9.6R2 COMPUTER HW IT ISOLATION TRANSFORMER MONITOR SPEAKER KIT PDM BASE STATION ETCO2 I/F RMOT KIT (MONITOR SOLD SEPARATELY) REMOTE MONITOR ACCESSORY KIT STANDARD COMPUTER ACCESSORIES PRE-INSTALL KIT NELLCOR SPO2 CABLE KIT MASIMO SPO2 CABLE KIT AHA ECG CABLE KIT IEC ECG CABLE KIT PDM STARTER KIT 230-V UPS 6.9.6R2 SPECIALSLAB SOFTWARE OPTIONS 6.9.6R2 SPECIALSLAB UPGRADE SW OPTIONS 240V SPECIALSLAB IEB 6.9.6R2 INW SERVER HW AND SW 6.9.6R2 INW SERVER ACCESSORIES 6.9.6R2 GE CLIENT WORKSATION HW AND SW 6.9.6R2 INVASIVE WORKBENCH OPTION FORMATTED DVD-RAM DISKS FOR ML/CL IT
Model Identifier(s)
2003422-001 2003423-001 2003424-001 2003425-001 2003426-001 2021462-001 P1003EM P1005DF P1007CD P1007O P1007OD P1007OF P1007OG P1007OL P1008CU P1008FF, P1008FG, P1008FH P1008M P1008MA P1008N P1008NA P1008PS P1008PT P1008PU P1008PW P1008PX P1008Q P1008SG P1009EM P1009EN P1009EO P1009EP P1009ES P1009ET P1009EU P1009EV P1009EZ P1009NJ P1961AA P1961BA P1961BB P1961BC P1961BD P1961BE P1961BF P1961CA P1961CC P1961CD P1961CE P1961CF P1961CG P1961CH P1961UB P1962AA P1962AC P1962BB P1966AA P1966AB P1966AC P1967AB PC-DVDF-A