Singapore HSA registration DE0510168
Roche Diagnostics Elecsys® Anti-HEV IgG
Singapore·CLASS C IVD·Roche Diagnostics GmbH·Registered December 19, 2024Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0510168
- Registration Date
- December 19, 2024
- Retention Due Date
- December 18, 2025
Product description
Immunoassay for the in vitro quantitative determination of IgG antibodies to the hepatitis E virus (HEV) in human serum and plasma. The Elecsys Anti‑HEV IgG assay is used as an aid to detect a recent or past HEV infection. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.
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)
- Elecsys® Anti-HEV IgG Elecsys® Anti-HEV IgG PreciControl Anti-HEV IgG
- Model Identifier(s)
- 9044639190 9044647190 9044655190
About this record
Access comprehensive regulatory information for Roche Diagnostics Elecsys® Anti-HEV IgG 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 DE0510168 and owned by Roche Diagnostics GmbH. The device was registered on December 19, 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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