Singapore HSA registration DE0013636
GE Mac-Lab Recording System
Singapore·CLASS C·GE Medical Systems Information Technologies, Inc.·Registered August 19, 2013Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Cardiovascular
- HSA Product Code
- HSAMDC00104
- HS Code
- 90181100
Registration information
- Registration Number
- DE0013636
- Registration Date
- August 19, 2013
- Change Notification Approval Date
- June 21, 2019
- Retention Due Date
- August 18, 2025
Product description
The Mac-Lab 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, 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).
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)
- 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 MACLAB 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) H45021BG, ENGLISH CART REGIONAL SUPPORT KIT (USA-110V) ANALOG OUT 16 CHANNELS 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 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 MLCL PDM MASIMO SPO2 ENGLISH 60HZ MLCL PDM MASIMO SPO2 ENGLISH 50HZ MLCL PDM NELLCOR SPO2 ENGLISH 60HZ MLCL PDM NELLCOR SPO2 ENGLISH 50HZ 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 MAC-LAB 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 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 PRE-INSTALL KIT 230-V UPS 6.9.6R2 MAC-LAB IT SOFTWARE OPTIONS 6.9.6R2 MAC-LAB XT SOFTWARE OPTIONS 6.9.6R2 MAC-LAB IT UPGRADE SW OPTIONS 6.9.6R2 MAC-LAB XT UPGRADE SW OPTIONS 6.9.6 MAC-LAB IT TO XT UPGRADE SW OPTIONS 240V MAC-LAB IEB 240V MAC-LAB IEB MAC-LAB 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 WORKSTATION HARDWARE AND SOFTWARE 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 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 P1007D P1007G P1007MH P1007MM P1007MY P1007O P1007OD P1007OF P1007OG P1007OH P1007OI P1007OJ P1007OK P1007OL P1007ON P1007PA P1007RA P1007RB P1007RC P1007RG P1008CU P1008M P1008MA P1008N P1008NA P1008PM P1008PS P1008PT P1008PU P1008PW P1008PX P1008Q P1008SE P1009EM P1009EN P1009EO P1009EP P1009ES P1009ET P1009EU P1009EV P1009EZ P1009NJ P1961AA P1961AB P1961AC P1961AD P1961AF P1961BA P1961BB P1961BC P1961BD P1961BE P1961BF P1961BG P1961CA P1961CB P1961CC P1961CD P1961CE P1961CF P1961CG P1961CH P1961CP P1961UB P1963AA P1963AB P1963AC P1963AD P1963AE P1963BB P1963BE P1963UM P1966AA P1966AB P1966AC P1966AD P1966AE P1966AF P1966CA P1966UM P1966UN P1966UP P1967AB PC-DVDF-A
About this record
Access comprehensive regulatory information for GE Mac-Lab 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 DE0013636 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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