Singapore HSA registration DE0510217
FUJIFILM AMULET SOPHINITY Digital Mammography System
Singapore·CLASS C·FUJIFILM CORPORATION·Registered January 08, 2025Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0510217
- Registration Date
- January 08, 2025
- Retention Due Date
- January 07, 2026
Product description
AMULET SOPHINITY is intended for screening and diagnostic mammography. AMULET SOPHINITY is indicated to visualization of breast for the purpose of diagnosis of breast disease.
Product Owner
- Short Name
- FUJIFILM
- Address
- 26-30 nishiazabu 2 chome, MINATO-KU TOKYO 106-8620 JAPAN, JAPAN
Registrant
- Address
- 10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Importer
- Address
- 10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Model information
- Model Name(s)
- FDR-4000AWS FUJIFILM Digital Mammography System
- Model Identifier(s)
- FDR-4000AWS FDR-4000DRLC
About this record
Access comprehensive regulatory information for FUJIFILM AMULET SOPHINITY Digital Mammography 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 DE0510217 and owned by FUJIFILM CORPORATION. The device was registered on January 08, 2025.
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