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Singapore HSA registration DE0510637

Siemens Syva® Emit® II Plus Ecstasy Assay

Singapore flagSingapore·CLASS B IVD·Siemens Healthcare Diagnostics Inc.·Registered April 25, 2025
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical toxicology
Registration information
Registration Number
DE0510637
Registration Date
April 25, 2025
Retention Due Date
April 24, 2026
Product description
The Emit® II Plus Ecstasy Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 500 ng/mL cutoff. The assay is intended for use in laboratories for the qualitative and/or semiquantitative analyses of methylenedioxymethamphetamine (MDMA) and closely related drugs in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.
Product Owner
Name
Siemens Healthcare Diagnostics Inc.
Short Name
Siemens Health
Address
500 GBC Drive, Mailstop 514,, PO Box 6101, Newark, DE 19714-6101,, 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)
Emit Calibrator/Control Level 0 Emit II Plus 6-AM/Ecstacy Calibrator/Control Level 1 Emit II Plus 6-AM/Ecstacy Calibrator/Control Level 2 Emit II Plus 6-AM/Ecstacy Calibrator/Control Level 3 Emit II Plus 6-AM/Ecstacy Calibrator/Control Level 4 Emit II Plus Ecstasy Assay Emit II Plus Ecstasy Assay
Model Identifier(s)
9A509UL 9R529UL 9R549UL 9R569UL 9R589UL 9X029UL 9X129UL
About this record

Access comprehensive regulatory information for Siemens Syva® Emit® II Plus Ecstasy Assay 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 DE0510637 and owned by Siemens Healthcare Diagnostics Inc.. The device was registered on April 25, 2025.

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 B IVD