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Siemens IMMULITE 2000 ACTH - HSA Registration DE0018669

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.

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CLASS B IVD
DE0018669
Siemens IMMULITE 2000 ACTH
HSA Registration Number: DE0018669
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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.

Device 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 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