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Siemens ADVIA Chemistry 1800, 2400, XPT Creatinine_2 (CREA_2) - HSA Registration DE0012195

Access comprehensive regulatory information for Siemens ADVIA Chemistry 1800, 2400, XPT Creatinine_2 (CREA_2) 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 DE0012195 and owned by Simens Healthcare Diagnostics Inc.. The device was registered on January 17, 2013.

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
DE0012195
Siemens ADVIA Chemistry 1800, 2400, XPT Creatinine_2 (CREA_2)
HSA Registration Number: DE0012195
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Product Description

For in vitro diagnostic use in the quantitative determination of creatinine in human serum, plasma (lithium heparin), and urine on ADVIA Chemistry systems. Such measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0012195
Registration Date
January 17, 2013
Change Notification Approval Date
August 23, 2018
Retention Due Date
January 16, 2026
Product Owner
Short Name
Siemens Health
Address
511 Benedict Avenue, Tarrytown, New York 10591-5097, New York, 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)
ADVIA Chemistry Creatinine_2 (CREA_2) Siemens Chemistry Calibrator
Model Identifier(s)
03039070 09784096 (PN T03-1291-62)