Singapore HSA registration DE0509738
OsteoSys PRIMUS X-Ray Bone Densitometer
Singapore·CLASS C·OsteoSys Co., Ltd·Registered September 05, 2024Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0509738
- Registration Date
- September 05, 2024
- Retention Due Date
- September 04, 2025
Product description
The PRIMUS system supports the doctor's activities for the diagnosis of osteoporosis and the prevention of future fractures to the patient through the measured BMD results. The PRIMUS system provides an estimate of body composition. The measurement sites in PRIMUS are the spine, femur, forearm and total body. Provides an estimate of bone mineral density at various anatomical sites (Spine, Femur, and Forearm). Provides an assessment of relative fracture risk based on the patient's T-score value using the categories of fracture risk defined by the World Health Organization (WHO).
Product Owner
- Short Name
- OsteoSys Co., Ltd
- Address
- 903, 9F, JnK Digital Tower Building, 111 Digital-ro, Guro-gu, Seoul, KOREA, REPUBLIC OF
Registrant
- Address
- 28 SIN MING LANE, MIDVIEW CITY, #02-143, SINGAPORE 573972
Importer
- Address
- 3006 UBI ROAD 1, KAMPONG UBI INDUSTRIAL ESTATE, #02-336, SINGAPORE 408700
Model information
- Model Name(s)
- PRIMUS
- Model Identifier(s)
- PRIMUS
About this record
Access comprehensive regulatory information for OsteoSys PRIMUS X-Ray Bone Densitometer in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509738 and owned by OsteoSys Co., Ltd. The device was registered on September 05, 2024.
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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