Siemens Syva® Emit® II Plus Ecstasy Assay - HSA Registration DE0510637
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.
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.