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Singapore HSA registration DE0501892

Siemens ADVIA Chemistry XPT system

Singapore flagSingapore·CLASS C IVD·Simens Healthcare Diagnostics Inc.·Registered July 13, 2018
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0501892
Registration Date
July 13, 2018
Change Notification Approval Date
September 28, 2023
Retention Due Date
July 12, 2025
Product description
The ADVIA® XPT Chemistry System is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes at a throughput rate of both 1800 photometric tests per hour and 600 electrolyte (ISE) tests per hour.
Product Owner
Name
Simens Healthcare Diagnostics Inc.
Short Name
Siemens Health
Address
511 Benedict Avenue, Tarrytown, New York 10591-5097, UNITED STATES
Registrant
Name
SIEMENS HEALTHCARE PTE. LTD.
Address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Importer
Name
SIEMENS HEALTHCARE PTE. LTD.
Address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Model information
Model Name(s)
ADVIA Chemistry Cuvette Conditioner ADVIA Chemistry Probe Wash 2 ADVIA Chemistry Sample Cups ADVIA Chemistry 20 mL Reagent Container ADVIA Chemistry 70 mL Reagent Container ADVIA Chemistry Probe Wash 3 ADVIA Chemistry Incubation Bath Oil ADVIA Chemistry 40 mL Reagent Container Reagent Wedge Adapter 40mL to 20mL ADVIA Chemistry Probe Wash 1 ADVIA Chemistry XPT Cuvette Detergent  ADVIA Chemistry XPT ISE Buffer 2  ADVIA Chemistry XPT ISE Baseline Solution ADVIA Chemistry XPT Probe Wash 0 Reagent Wedge Adapter 70mL to 40mL Reagent Wedge Adapter 70mL to 20mL ADVIA Chemistry XPT Analyzer Test Definition Kit ADVIA Chemistry XPT Workstation Kit
Model Identifier(s)
00361699 04007474 073-0157-02 073-0372-03 073-0373-03 08988437 09323099 094-0123-02 094-0159-01 09467716 10718753 10718754 10718755 10718756 10719152 10723030 10723034 11127343 11127440
About this record

Access comprehensive regulatory information for Siemens ADVIA Chemistry XPT system in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0501892 and owned by Simens Healthcare Diagnostics Inc.. The device was registered on July 13, 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 C IVD