Singapore HSA registration DE0015965
ORGENTEC Diagnostika Alegria Anti-Annexin V IgG/IgM
Singapore·CLASS B IVD·ORGENTEC Diagnostika GmbH·Registered July 14, 2014Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Immunology
- HSA Product Code
- HSAMDB00106
- HS Code
- 38220090
Registration information
- Registration Number
- DE0015965
- Registration Date
- July 14, 2014
- Retention Due Date
- July 13, 2025
Product description
Anti-Annexin V IgG/IgM is an indirect solid phase enzyme immunoassay (ELISA) for the quantitative measurement of IgG and IgM class autoantibodies against Annexin V in human serum or plasma. The assay is intended for in vitro diagnostic use only as an aid in the diagnosis of an increased risk of thrombosis and recurrent fetal loss.
Product Owner
- Short Name
- ORGENTEC Diagnostika GmbH
- Address
- Carl-Zeiss-Strasse 49-51, 55129 Mainz, Mainz, Rheinland-Pfalz, GERMANY
Registrant
- Address
- 627A ALJUNIED ROAD, BIZTECH CENTRE, #08-09, SINGAPORE 389842
Importer
- Address
- 627A ALJUNIED ROAD, BIZTECH CENTRE, #08-07/09, SINGAPORE 389842
Model information
- Model Name(s)
- Anti-Annexin V IgG/IgM
- Model Identifier(s)
- ORG 643
About this record
Access comprehensive regulatory information for ORGENTEC Diagnostika Alegria Anti-Annexin V IgG/IgM in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0015965 and owned by ORGENTEC Diagnostika GmbH. The device was registered on July 14, 2014.
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 B IVD