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GE ComboLab Recording System - HSA Registration DE0013633

Access comprehensive regulatory information for GE ComboLab 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 DE0013633 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
DE0013633
GE ComboLab Recording System
HSA Registration Number: DE0013633
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Product Description

The ComboLab System is the combination of both the Mac-Lab and CardioLab Systems and is 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, Fractional Flow Reserve (FFR), invasive and noninvasive blood pressure), intracardiac signals, stimulus data and ablation data.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Cardiovascular
HSA Product Code
HSAMDC00104
HS Code
90181100
Registration Information
Registration Number
DE0013633
Registration Date
August 19, 2013
Change Notification Approval Date
June 21, 2019
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
Model Information
Model Name(s)
CABLE ASSY CINCH MDC-7P15 Cable, ECG, Prucka CardioLab, 10-Ld, AHA, 10K Resistors, 3 m Cable, ECG, Prucka CardioLab, 10-Ld, AHA, 10K Resistors, 4.5 m 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 Cable, Prucka, Duplex Fiber Optic, ST/FDDI, 75 ft., 22.6m DISK DVD-RAM CARTRIDGE 9.4 GB FORMATTED Catheter Input Module for CLab II Plus Amplifiers (w/Protected Pin Modification) Cable, CLab II Plus Amplifier Stim, 3 ft. Extender Cable for interfacing EP Stimulator, 4.5 m Extender Cable for interfacing EP Stimulator, 9 m COMBOLAB ENGLISH LANGUAGE KEYBOARD GE BEDSIDE MONITOR INTERFACE CABLES H45031SD, MULTI-POINT CONNECTIVITY KIT H45021CS, SAFELOCK CART (100-120V) VIVID CARTOSOUND INTERFACE KIT H45021BG, ENGLISH CART REGIONAL SUPPORT KIT (USA-110V) H45031AM, ICE USER MANUAL ENGLISH ANALOG OUT 16 CHANNELS CARTO INTERFACE ONLY ETCO2 INTERFACE ONLY 3RD PARTY XRAY INTERFACE DCIOM ONLY ADT DICOM MWL 3RD PARTY PEDCATH SOFTWARE KIT PEDCATH SOFTWARE KIT ENTERPRISE PEDCATH SOFTWARE KIT UNICODE CARDIOIMAGE SOFTWARE MODULE ONLY CA1000 DICOM VIEWER SOFTWARE LICENSE CARDIOICE INTERFACE KIT - CE VIVID BED-RAIL MOUNT FORCE SENSING DISPLAY H45041M, CARDIOICE VIVIDI BASE (BT12) H45041P, CARDIOICE VIVIDI FULL (BT12) H45041R, CARDIOICE VIVIDQ FULL (BT12) H45041KB, VIVID I Q BT12 ENG INT REGIONAL LANG BARCODE SCANNER Centricity Cardiology INW Server KIT CLAB II PLUS - 128 CHANNELS - ROHS KIT CLAB II PLUS - 64 CHANNELS - ROHS MLCL PDM MASIMO SPO2 ENGLISH 60HZ MLCL PDM MASIMO SPO2 ENGLISH 50HZ MLCL PDM NELLCOR SPO2 ENGLISH 60HZ MLCL PDM NELLCOR SPO2 ENGLISH 50HZ CARDIOLAB COMBOLAB V6.9.5 PDM PRE-INSTALL CABLE KIT CARDIO TREE OPTION 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 ABLATION INTERFACE CABLE SET 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 ISOLATION TRANSFORMER FOR REMOTE MONITOR LABELS FOR CATHETER INPUT MODULES SINGAPORE POWER CORD 6.9.6R2 COMPUTER HW IT 6.9.6R2 COMPUTER HW XT 6.9.6R3 COMPUTER HW IT 6.9.6R3 COMPUTER HW XT 6.9.6R3 TRAMNET UPGRADE ISOLATION TRANSFORMER MONITOR (FOR BOOM) SPEAKER KIT PDM BASE STATION ETCO2 I/F RMOT KIT (MONITOR SOLD SEPARATELY) REMOTE MONITOR ACCESSORY KIT CARDIOICE LICENSE AND INTERFACE KIT STANDARD COMPUTER ACCESSORIES IMAGE-CAPTURE CABLES PRE-INSTALL KIT NELLCOR SPO2 CABLE KIT MASIMO SPO2 CABLE KIT AHA ECG CABLE KIT IEC ECG CABLE KIT PDM CABLE STARTER KIT FIBER OPTIC FDDI CABLE PREINSTALL KIT FOR CARDIOLAB/COMBOLAB PRE-INSTALL KIT 230-V UPS 6.9.6R2 COMBOLAB IT SOFTWARE AND HARDWARE PACKAGE 6.9.6R2 COMBOLAB XT SOFTWARE AND HARDWARE PACKAGE 6.9.6R2 COMBOLAB IT UPGRADE SW OPTIONS 6.9.6R2 COMBOLAB XT UPGRADE SW OPTIONS 6.9.6 COMBOLAB IT TO XT UPGRADE SW OPTIONS 240V COMBOLAB IEB 240V COMBOLAB IEB COMBOLAB 6.9.6R3 UPGRADE FROM 6.9.6R2 6.9.6R2 INW SERVER HW AND SW 6.9.6R2 INW SERVER ACCESSORIES 6.9.6R2 GE CLIENT WORKSATION HW AND SW 6.9.6R3 INW SERVER HW AND SW 6.9.6R3 INW SERVER ACCESSORIES 6.9.6R3 GE CLIENT WORKSATION HW AND SW CARESCAPE INTERFACE INW SERVER V6.9.6R3 UPGRADE FROM 6.9.6R2 GE CLIENT WORKSTATION V6.9.6R3 UPGRADE FROM 6.9.6R2 VM CLIENT V6.9.6R3 UPGRADE FROM 6.9.6R2 6.9.6R2 INVASIVE WORKBENCH OPTION CABLE , ECG, 10LEAD, SHIELDED 15FT CABLE LEAD SET, ECG, SHIELDED, EURO, 36" LDWR SET-GRAB/RDTRANS-AHA-36IN 5/SET LDWR SET-GRAB/RDTRANS-AHA-72IN 10/SET LDWR SET-GRAB-AHA-72IN 10/SET(NO RDTRAN) LDWR SET-GRAB/RDTRANS-IEC-72IN 10/SET CABLE STIM INPT TCHPRF 30FT CLABII+ CABLE STIM EXTENDER, 3FT DUAL TOUCHPROOF FORMATTED DVD-RAM DISKS FOR ML/CL IT
Model Identifier(s)
2000633-001 2003419-001 2003420-001 2003422-001 2003423-001 2003424-001 2003425-001 2003426-001 2003434-001 2021462-001 301-00202-08 301-00204-03 301-00207-15 301-00207-30 P1005DF P1007CD P1007MH P1007MM P1007MP P1007MY P1007NB P1007O P1007OA P1007OD P1007OF P1007OG P1007OH P1007OI P1007OJ P1007OK P1007OL P1007ON P1007PA P1007PR P1007RA P1007RB P1007RC P1007RG P1008CU P1008FF, P1008FG, P1008FH P1008HU P1008HV P1008M P1008MA P1008N P1008NA P1008PB P1008PM P1008PS P1008PT P1008PU P1008PW P1008PX P1008Q P1008SH P1008TA P1009EM P1009EN P1009EO P1009EP P1009ES P1009ET P1009EU P1009EV P1009EZ P1009JG P1009JN P1009NJ P1961AA P1961AB P1961AC P1961AD P1961AF P1961BA P1961BB P1961BC P1961BD P1961BE P1961BF P1961BG P1961CA P1961CB P1961CC P1961CD P1961CE P1961CF P1961CG P1961CH P1961CL P1961CP P1961UB P1965AA P1965AB P1965AC P1965AD P1965AE P1965BB P1965BE P1965UM P1966AA P1966AB P1966AC P1966AD P1966AE P1966AF P1966CA P1966UM P1966UN P1966UP P1967AB P1967CA P1967CB P1967CC P1967CD P1967CE P1967CF P1967CG P1967CH PC-DVDF-A