Singapore HSA registration DE0509913
Roche Diagnostics Elecsys® Anti-HEV IgM
Singapore·CLASS C IVD·Roche Diagnostics GmbH·Registered October 15, 2024Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0509913
- Registration Date
- October 15, 2024
- Retention Due Date
- October 14, 2025
Product description
Immunoassay for the in vitro qualitative detection of IgM antibodies to the hepatitis E virus (HEV) in human serum and plasma. The Elecsys Anti‑HEV IgM assay is used as an aid to detect an acute or recently acquired 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 IgM Elecsys® Anti-HEV IgM PreciControl Anti-HEV IgM
- Model Identifier(s)
- 9056246190 9056254190 9056289190
About this record
Access comprehensive regulatory information for Roche Diagnostics Elecsys® Anti-HEV IgM 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 DE0509913 and owned by Roche Diagnostics GmbH. The device was registered on October 15, 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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