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Singapore HSA registration DE0502122

Siemens Emit® 2000 Theophylline Assay

Singapore flagSingapore·CLASS C IVD·Siemens Healthcare Diagnostics Inc.·Registered September 06, 2018
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0502122
Registration Date
September 06, 2018
Retention Due Date
September 05, 2025
Product description
The Emit® 2000 Theophylline Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma. These reagents are packaged specifically for use on a variety of AU® Clinical Chemistry Systems
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 Theophylline Calibrators AU5800 Optional Analyzer AU480 Program DVD v1.91 AU5800 Program DVD v5.03 AU680 Program DVD v4.05 AU481-10, Win7, CHEMISTRY ANALYZER AU480 AU681-10, Win7, CHEMISTRY ANALYZER AU680 AU5800-10, CHEMISTRY ANALYZER AU5800 AU5800-20, Win7, CHEMISTRY ANALYZER AU5800, Automation Ready Emit® 2000 Theophylline Assay
Model Identifier(s)
4P109UL B23281 B83467 B84634 B91804 B96692 B96694 B96697 B96698 OSR4P229
About this record

Access comprehensive regulatory information for Siemens Emit® 2000 Theophylline 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 DE0502122 and owned by Siemens Healthcare Diagnostics Inc.. The device was registered on September 06, 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