GE CardioLab Recording System - HSA Registration DE0013635
Access comprehensive regulatory information for GE CardioLab 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 DE0013635 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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HSA Official Data
CLASS C
DE0013635
GE CardioLab Recording System
HSA Registration Number: DE0013635
Product Description
The CardioLab System 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, intracardiac signals, stimulus data, ablation data, pulse oximetry (SpO2), respiration rate, CO2 (EtCO2), temperature, and 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
DE0013635
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
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
CARDIOLAB ENGLISH LANGUAGE KEYBOARD
COMBOLAB ENGLISH LANGUAGE KEYBOARD
GE BEDSIDE MONITOR INTERFACE CABLES
REAL TIME SCROLLING KIT
3RD PARTY HL7 INTERFACE
H45031SD, MULTI-POINT CONNECTIVITY KIT
H45021CS, SAFELOCK CART (100-120V)
VIVID CARTOSOUND INTERFACE KIT
H45021BG, ENGLISH CART REGIONAL SUPPORT KIT (USA-110V)
ANALOG OUT 16 CHANNELS
CARTO INTERFACE ONLY
ETCO2 INTERFACE ONLY
3RD PARTY XRAY INTERFACE DCIOM ONLY
ADT DICOM MWL 3RD PARTY
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
KIT CLAB II PLUS - 128 CHANNELS
KIT CLAB II PLUS - 64 CHANNELS
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
IEB 240V CARDIOLAB
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
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
SPEAKER KIT
PDM BASE STATION ETCO2 I/F
RMOT KIT (MONITOR SOLD SEPARATELY)
REMOTE MONITOR ACCESSORY KIT
CARDIOICE LICENCE 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 CARDIOLAB IT SOFTWARE OPTIONS
6.9.6R2 CARDIOLAB XT SOFTWARE OPTIONS
6.9.6R2 CARDIOLAB IT UPGRADE SW OPTIONS
6.9.6R2 CARDIOLAB XT UPGRADE SW OPTIONS
6.9.6 CARDIOLAB IT TO XT UPGRADE SW OPTIONS
240V CARDIOLAB IEB
240V CARDIOLAB IEB, 6.9.6R3
CARDIOLAB 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 (R3 Only)
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
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
P1004DF
P1005DF
P1007CD
P1007D
P1007G
P1007MH
P1007MM
P1007MP
P1007MY
P1007O
P1007OA
P1007OD
P1007OF
P1007OG
P1007OK
P1007OL
P1007ON
P1007PA
P1007PR
P1007RA
P1007RB
P1007RC
P1007RG
P1008CU
P1008HU
P1008HV
P1008M
P1008MA
P1008N
P1008NA
P1008PS
P1008PT
P1008PU
P1008PW
P1008PX
P1008SF
P1008TA
P1009EM
P1009EN
P1009EO
P1009EP
P1009ES
P1009ET
P1009EU
P1009EV
P1009EZ
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
P1964AA
P1964AB
P1964AC
P1964AD
P1964AE
P1964BB
P1964BE
P1964UM
P1966AA
P1966AB
P1966AC
P1966AD
P1966AE
P1966AF
P1966CA
P1966UM
P1966UN
P1966UP
P1967AB
P1967CA
P1967CB
P1967CC
P1967CD
P1967CE
P1967CF
P1967CG
P1967CH
PC-DVDF-A