Singapore HSA registration DE0018669
Siemens IMMULITE 2000 ACTH
Singapore·CLASS B IVD·Siemens Healthcare Diagnostics Products Limited·Registered October 14, 2016Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0018669
- Registration Date
- October 14, 2016
- Change Notification Approval Date
- November 18, 2021
- Retention Due Date
- October 13, 2025
Product description
For in vitro diagnostics use with the IMMULITE 2000 Systems Analyzers – for the quantitative measurement of adrenocorticotropic hormone in EDTA plasma, as an aid in the assessment of adrenal insufficiency and hypersecretion.
Product Owner
- Short Name
- Siemens Healthcare Diagnostics Products Limited
- Address
- Gly Rhonwy, Llanberis, Gwynedd LL55 4EL, UNITED KINGDOM
Registrant
- Address
- 60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Importer
- Address
- 60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Model information
- Model Name(s)
- IMMULITE 2000 ACTH Bi-level ACTH control module (protein-based)
- Model Identifier(s)
- L2KAC2 LACCM
About this record
Access comprehensive regulatory information for Siemens IMMULITE 2000 ACTH 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 DE0018669 and owned by Siemens Healthcare Diagnostics Products Limited. The device was registered on October 14, 2016.
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