Singapore HSA registration DE0015903
ORGENTEC Diagnostika Anti-Phospholipid IgG/IgM kits
Singapore·CLASS B IVD·ORGENTEC Diagnostika GmbH·Registered July 09, 2014Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Immunology
- HSA Product Code
- HSAMDB00106
- HS Code
- 38220090
Registration information
- Registration Number
- DE0015903
- Registration Date
- July 09, 2014
- Change Notification Approval Date
- February 14, 2023
- Retention Due Date
- July 08, 2025
Product description
Quantitative enzyme immunoassay (EIA) intended to screen for the presence of IgG and IgM class autoantibodies against cardiolipin, phosphatidyl serine, phosphatidyl inositol, phosphatidic acid and beta-2-glycoprotein I in human serum or plasma as an aid in the diagnosis of an increased risk of thrombosis in patients with systemic lupus erythematosus (SLE) or lupus-like disorders.
Product Owner
- Short Name
- ORGENTEC Diagnostika GmbH
- Address
- Carl-Zeiss-Strasse 49-51, 55129 Mainz, Mainz, Rheinland-Pfalz, GERMANY
Registrant
- Address
- 51 CHANGI BUSINESS PARK CENTRAL 2, THE SIGNATURE, #09-12, SINGAPORE 486066
Importer
- Address
- 51 CHANGI BUSINESS PARK CENTRAL 2, THE SIGNATURE, #09-12, SINGAPORE 486066
Model information
- Model Name(s)
- Anti-Phospholipid Screen IgG/IgM Anti-Phosphatidyl Serine IgG/IgM Anti-Phosphatidyl Inositol IgG/IgM Anti-Phosphatidic Acid IgG/IgM
- Model Identifier(s)
- ORG 529 ORG 535 ORG 536 ORG 537
About this record
Access comprehensive regulatory information for ORGENTEC Diagnostika Anti-Phospholipid IgG/IgM kits 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 DE0015903 and owned by ORGENTEC Diagnostika GmbH. The device was registered on July 09, 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