Singapore HSA registration DE0510389
Roche Diagnostics uPath HER2 Dual ISH image analysis for Breast Algorithm
Singapore·CLASS C IVD·Roche Diagnostics GmbH·Registered February 25, 2025Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Pathology
Registration information
- Registration Number
- DE0510389
- Registration Date
- February 25, 2025
- Retention Due Date
- February 24, 2026
Product description
The uPath HER2 Dual ISH image analysis for Breast algorithm is intended for use as an aid to the pathologist to determine HER2 gene status by enumeration of the ratio of the HER2 gene to Chromosome 17, in formalin-fixed, paraffin-embedded neoplastic breast tissue specimens. When used with the VENTANA HER2 Dual ISH Assay, it is indicated as an aid in the assessment of breast cancer patients for whom Herceptin® (trastuzumab) treatment is being considered.
Product Owner
- Short Name
- Roche Diagnostics GmbH
- Address
- Sandhofer Strasse 116, 68305 Mannheim, GERMANY
Registrant
- Address
- 8 KALLANG AVENUE, APERIA, #10-01/09, SINGAPORE 339509
Importer
- Address
- 8 KALLANG AVENUE, APERIA, #10-01/09, SINGAPORE 339509
Model information
- Model Name(s)
- Roche Diagnostics uPath HER2 Dual ISH image analysis for Breast Algorithm
- Model Identifier(s)
- 09103546001 / 09134433001
About this record
Access comprehensive regulatory information for Roche Diagnostics uPath HER2 Dual ISH image analysis for Breast Algorithm in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0510389 and owned by Roche Diagnostics GmbH. The device was registered on February 25, 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 IVD