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Integra Integra Licox® PtO2 Monitor - HSA Registration DE0510236

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.

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CLASS C
DE0510236
Integra Integra Licox® PtO2 Monitor
HSA Registration Number: DE0510236
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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.

Device 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 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