Singapore HSA registration DE0509450
Thermo Scientific Sensititre MIC and Breakpoint Susceptibility system
Singapore·CLASS B IVD·Trek Diagnostic Systems Ltd·Registered June 24, 2024Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Microbiology
Registration information
- Registration Number
- DE0509450
- Registration Date
- June 24, 2024
- Retention Due Date
- June 23, 2025
Product description
The Sensititre MIC and Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious Gram negative isolates, comprising of Enterobacteriaceae, Pseudomonas aeruginosa, and other non-Enterobacteriaceae and of non-fastidious Gram positive isolates, comprising of Staphylococcus sp., Enterococcus sp., and Beta haemolytic Streptococci other than S. pneumoniae. The Sensititre ESBL confirmatory test plate is an in vitro diagnostic product for detection of ESBLs in clinical isolates of Klebsiella pneumoniae, Klebsiella oxytoca and Escherichia coli. MIC and ESBL plates can either be read manually or automatically on the Sensititre Autoreader / OptiRead and/or ARIS. Thermo Scientific manufactured broths have only been validated with Sensititre products
Product Owner
- Short Name
- Trek Diagnostic Systems Ltd
- Address
- Units 17 - 19, Birches Industrial Estate, East Grinstead, West Sussex, UNITED KINGDOM
Registrant
- Address
- 33 MARSILING IND ESTATE ROAD 3, #07-06, SINGAPORE 739256
Importer
- Address
- 33 MARSILING IND ESTATE ROAD 3, #07-06, SINGAPORE 739256
Model information
- Model Name(s)
- Sensititre SWIN software System Sensititre Optiread Plate Dry CLI Gram-Auto
- Model Identifier(s)
- SW534 V3030 YGN4F
About this record
Access comprehensive regulatory information for Thermo Scientific Sensititre MIC and Breakpoint Susceptibility system 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 DE0509450 and owned by Trek Diagnostic Systems Ltd. The device was registered on June 24, 2024.
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