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Siemens IMMULITE 2000 Immunoassay Systems - HSA Registration DE0502087

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.

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CLASS D IVD
DE0502087
Siemens IMMULITE 2000 Immunoassay Systems
HSA Registration Number: DE0502087
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Product Description

The IMMULITE 2000 and IMMULITE 2000 XPi are continuous random-access systems that perform chemiluminescent immunoassays.

Device 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 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