Singapore HSA registration DE0007988
GE ApexPro Telemetry System
Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Cardiovascular
- HSA Product Code
- Refer to CRPNS
- HS Code
- 90189030
Registration information
- Registration Number
- DE0007988
- Registration Date
- November 22, 2011
- Retention Due Date
- November 21, 2025
Product description
is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The ApexPro Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered. The physiological parameters monitored include ECG, non-invasive blood pressure, non-invasive temperature and SpO2. The ApexPro Telemetry System is intended to provide ECG data via Ethernet to the computer platform for processing.
Product Owner
- Short Name
- GE Medical Systems
- Address
- 8200 West Tower Avenue, Milwaukee, WI 53223, 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)
- ApexPro International Passive Antenna 420-474 MHZ ApexPro International Active Antenna 420-474 MHZ APEXPRO RECEIVER SUBSYSTEM APEXPRO RECEIVER SUBSYSTEM APEXPRO RECEIVER SUBSYSTEM APEXPRO RECEIVER SUBSYSTEM APEXPRO RECEIVER SUBSYSTEM APEXPRO QUAD RECEIVER MODULE ApexPro Transmitter ApexPro CH NONIN Xpod Oximeter CARESCAPE TELEMETRY SERVER
- Model Identifier(s)
- 2000673-005 2000673-008 APRO-00-SG-ENG-2 APRO-04-SG-ENG-2 APRO-08-SG-ENG-2 APRO-12-SG-ENG-2 APRO-16-SG-ENG-2 APRO4RCVR-SG-ENG-2 APROTX-SG-ENG-AHA-3 TLM-XPOD-CH=ENG TLMSV-CH-A-ENG-XXXXX
About this record
Access comprehensive regulatory information for GE ApexPro Telemetry 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 DE0007988 and owned by GE Medical Systems Information Technologies. The device was registered on November 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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