Singapore HSA registration DE0509587
Thermo Scientific MAS® Omni•CARDIO™
Singapore·CLASS C IVD·Microgenics Corporation·Registered July 25, 2024Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0509587
- Registration Date
- July 25, 2024
- Retention Due Date
- July 24, 2025
Product description
Thermo Scientific MAS® Omni•CARDIO™ is intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions related to cardiac and associated critical marker determinations.
Product Owner
- Short Name
- Microgenics Corporation
- Address
- 46500 Kato Road,, Fremont, CA 94538, UNITED STATES
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)
- MAS® Omni•CARDIO™ Liquid Assayed Integrated Cardiac Control
- Model Identifier(s)
- OCRD-UL
About this record
Access comprehensive regulatory information for Thermo Scientific MAS® Omni•CARDIO™ 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 DE0509587 and owned by Microgenics Corporation. The device was registered on July 25, 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 C IVD