Singapore HSA registration DE0508087
GE Allia IGS 5
Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0508087
- Registration Date
- May 12, 2023
- Change Notification Approval Date
- July 24, 2024
- Retention Due Date
- May 11, 2026
Product description
The angiographic X-Ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR Table, the angiographic X-Ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR Table is suitable for interventional and surgical procedures.
Product Owner
- Short Name
- GE Medical Systems SCS
- Address
- 283 RUE DE LA MINIERE, 78530 BUC FRANCE, FRANCE
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)
- Allia IGS 5
- Model Identifier(s)
- 5872892
About this record
Access comprehensive regulatory information for GE Allia IGS 5 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508087 and owned by GE Medical Systems SCS. The device was registered on May 12, 2023.
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