Singapore HSA registration DE0510236
Integra Integra Licox® PtO2 Monitor
Singapore·CLASS C·Integra LifeSciences (Ireland) Ltd·Registered January 14, 2025Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Neurology
Registration information
- Registration Number
- DE0510236
- Registration Date
- January 14, 2025
- Retention Due Date
- January 13, 2026
Product description
The Integra® Licox® PtO2 Monitor measures oxygen partial pressure (PtO2) and temperature in brain tissue and these parameters are used together as an aid in the determination of the perfusion status of cerebral tissue local to sensor placement. Monitor values are relative within an individual, and should not be used as the sole basis for determining a diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice in cases where hypoxia or ischemia are a concern.
Product Owner
- Short Name
- Integra LifeSciences (Ireland) Ltd
- Address
- IDA Business & Technology Park, Sragh, Tullamore, County Offaly, IRELAND
Registrant
- Address
- 1 KALLANG JUNCTION, Vanguard Campus, #05-01, SINGAPORE 339263
Importer
- Address
- 1 KALLANG JUNCTION, #05-01, SINGAPORE 339263
Model information
- Model Name(s)
- 14.4V Lithium Ion Battery Licox PT02 monitor Cable Kit Licox® Probe Cable PtO2 probe cable Licox® Probe Cable PtO2 probe extension cable Licox® Probe Test Set Licox® Probe Cable Temperature probe cable Licox® Probe Cable Temperature probe extension cable USB-to-RS232 adaptor cable Licox® PtO2 Monitor Oxygen Partial Pressure and Temperature Monitor 18V DC 1.67 A, 30 W AC Power Adapter Patient Monitor Cable Licox® Probe Cable Combined PtO2/temp probe cable
- Model Identifier(s)
- BAT1001 BC10 BC10PA BC10PV BC10R BC10TA BC10TV EXPORTCAB LCX02 MONPWR PMIOMPM-1 PMOCAB
About this record
Access comprehensive regulatory information for Integra Integra Licox® PtO2 Monitor in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510236 and owned by Integra LifeSciences (Ireland) Ltd. The device was registered on January 14, 2025.
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C