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Singapore HSA registration DE0017445

Hologic Horizon DXA System

Singapore flagSingapore·CLASS C·Hologic Inc.·Registered August 27, 2015
Device classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
HSA Product Code
Refer to CRPNS
HS Code
90221400
Registration information
Registration Number
DE0017445
Registration Date
August 27, 2015
Change Notification Approval Date
May 15, 2025
Retention Due Date
August 26, 2025
Product description
Indicated for the estimation of bone mineral density (BMD), comparison of measured variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics using the Hologic QDR® X-Ray Bone Densitometers.
Product Owner
Name
Hologic Inc.
Short Name
Hologic Inc.
Address
600 Technology Drive, Newark, DE 19702, UNITED STATES
Registrant
Name
ITS SCIENCE & MEDICAL PTE LTD
Address
219 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #08-02, SINGAPORE 159556
Importer
Name
ITS SCIENCE & MEDICAL PTE LTD
Address
219 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #08-02, SINGAPORE 159556
Model information
Model Name(s)
Horizon A Horizon C Horizon Ci Horizon W Horizon Wi
Model Identifier(s)
Horizon-A Horizon-C Horizon-Ci Horizon-W Horizon-Wi
About this record

Access comprehensive regulatory information for Hologic Horizon DXA System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0017445 and owned by Hologic Inc.. The device was registered on August 27, 2015.

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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