Singapore HSA registration DE0509720
g.tec cortiQ PRO
Singapore·CLASS C·g.tec medical engineering GmbH·Registered September 03, 2024Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Neurology
Registration information
- Registration Number
- DE0509720
- Registration Date
- September 03, 2024
- Retention Due Date
- September 02, 2025
Product description
The system is intended to statistically evaluate brain activity reflected in a broad band of high-gamma frequencies in the human electroencephalogram (EEG). These measures should always be interpreted in conjunction with review of the original EEG waveform. cortiQ PRO is intended for the evaluation of intracranial EEG recorded with the g.HIamp. The device must be used either by a medical expert, such as a medical doctor with expertise in neurology or neurosurgery, or by a medical technical expert such as neuroscience specialists. A user is only eligible to operate the device after completing device training.
Product Owner
- Short Name
- g.tec medical engineering GmbH
- Address
- Sierningstraße 14 4521 Schiedlberg, AUSTRIA
Registrant
- Name
- AUGXANO PTE LTD
- Address
- 60 PAYA LEBAR ROAD, PAYA LEBAR SQUARE, #05-08, SINGAPORE 409051
Model information
- Model Name(s)
- g.HIamp 80 channels g.HIamp 144 channels g.HIamp 256 channels cortiQ PRO
- Model Identifier(s)
- 7001US 7002US 7003US 8060
About this record
Access comprehensive regulatory information for g.tec cortiQ PRO in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509720 and owned by g.tec medical engineering GmbH. The device was registered on September 03, 2024.
This page provides complete registration details including product owner information, registrant details, 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