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Singapore HSA registration DE0503243

Siemens Emit® 2000 Digoxin Assay

Singapore flagSingapore·CLASS C IVD·Siemens Healthcare Diagnostics Inc.·Registered June 18, 2019
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0503243
Registration Date
June 18, 2019
Retention Due Date
June 17, 2025
Product description
The Emit® 2000 Digoxin Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of digoxin in human serum or plasma. These reagents are packaged specifically for use on a variety of AU® Clinical Chemistry Systems. Measurements obtained from this device are used in the diagnosis and treatment of digoxin overdose or in monitoring levels of digoxin to ensure appropriate therapy.
Product Owner
Name
Siemens Healthcare Diagnostics Inc.
Short Name
Siemens Healthcare Diagnostics Inc.
Address
500 GBC Drive, Mailstop 514, PO Box 6101, Newark, DE 19714 USA, UNITED STATES
Registrant
Name
BECKMAN COULTER SINGAPORE PTE. LTD.
Address
70 BENDEMEER ROAD, LUZERNE, #03-04, SINGAPORE 339940
Importer
Name
BECKMAN COULTER SINGAPORE PTE. LTD.
Address
70 BENDEMEER ROAD, LUZERNE, #03-04, SINGAPORE 339940
Model information
Model Name(s)
Emit ® 2000 Digoxin Calibrators AU680 Program DVD v4.05 CHEMISTRY ANALYZER AU680 Emit® 2000 Digoxin Assay
Model Identifier(s)
4H209UL B91804 B96694 OSR4H229
About this record

Access comprehensive regulatory information for Siemens Emit® 2000 Digoxin Assay 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 DE0503243 and owned by Siemens Healthcare Diagnostics Inc.. The device was registered on June 18, 2019.

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