Singapore HSA registration DE0502087
Siemens IMMULITE 2000 Immunoassay Systems
Singapore·CLASS D IVD·Siemens Healthcare Diagnostics Inc.·Registered August 29, 2018Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0502087
- Registration Date
- August 29, 2018
- Change Notification Approval Date
- October 16, 2024
- Retention Due Date
- August 28, 2025
Product description
The IMMULITE 2000 and IMMULITE 2000 XPi are continuous random-access systems that perform chemiluminescent immunoassays.
Product Owner
- Short Name
- Siemens Healthcare Diagnostics Inc.
- Address
- 62 Flanders-Bartley Road, Flanders, NJ 07836-4715, UNITED STATES
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 System IMMULITE 2000 XPi System IMMULITE 2000 Probe Cleaning Kit IMMULITE 2000 Probe Wash Module
- Model Identifier(s)
- 030002-13 030002-33 L2KPM L2PWSM
About this record
Access comprehensive regulatory information for Siemens IMMULITE 2000 Immunoassay Systems in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0502087 and owned by Siemens Healthcare Diagnostics Inc.. The device was registered on August 29, 2018.
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 D IVD