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Singapore HSA registration DE0506638

GE Allia IGS Medical X-Ray Angiography Systems

Singapore flagSingapore·CLASS C·GE Medical Systems SCS·Registered February 10, 2022
Device classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0506638
Registration Date
February 10, 2022
Change Notification Approval Date
April 22, 2025
Retention Due Date
February 09, 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
Name
GE Medical Systems SCS
Short Name
GE Medical Systems SCS
Address
283 RUE DE LA MINIERE, 78530 BUC FRANCE, FRANCE
Registrant
Name
GE HEALTHCARE PTE. LTD.
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
Name
GE HEALTHCARE PTE. LTD.
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Model information
Model Name(s)
Allia IGS 7 Allia IGS 7 OR
Model Identifier(s)
5855628 5855630
About this record

Access comprehensive regulatory information for GE Allia IGS Medical X-Ray Angiography Systems in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0506638 and owned by GE Medical Systems SCS. The device was registered on February 10, 2022.

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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