Singapore HSA registration DE0505440
Thermo Scientific MAS® CardioImmune · XL
Singapore·CLASS C IVD·Microgenics Corporation·Registered February 05, 2021Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0505440
- Registration Date
- February 05, 2021
- Retention Due Date
- February 04, 2026
Product description
MAS® CardioImmune · XL is intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac 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
- 1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Model information
- Model Name(s)
- MAS® CardioImmune® · XL Level 1 MAS® CardioImmune® · XL Level 2 MAS® CardioImmune® · XL Level 3 MAS® CardioImmune® · XL Level 1-3 MAS® CardioImmune® · XL Level L
- Model Identifier(s)
- CAI-XL1 CAI-XL2 CAI-XL3 CAI-XL4 CAI-XLL
About this record
Access comprehensive regulatory information for Thermo Scientific MAS® CardioImmune · XL 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 DE0505440 and owned by Microgenics Corporation. The device was registered on February 05, 2021.
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