Singapore HSA registration DE0012240
Sentinel Diagnostics CK-MB
Singapore·CLASS C IVD·Sentinel CH. SpA·Registered January 31, 2013Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0012240
- Registration Date
- January 31, 2013
- Change Notification Approval Date
- October 15, 2024
- Retention Due Date
- January 30, 2026
Product description
The CK-MB assay is intended for in vitro diagnostic use in the kinetic determination of the CK-MB and CK-BB isoenzymes of creatine kinase in serum or plasma on the ARCHITECT c Systems. Measurement of the CK- MB and CK-BB isoenzymes is used as an aid in the diagnosis and follow-up of patients suspected of having an acute myocardial infarction (AMI). For laboratory professional use only.
Product Owner
- Name
- Sentinel CH. SpA
- Short Name
- SENTINEL CH. SpA
- Address
- Via Robert Koch, 2, Milan 20152, ITALY
Registrant
- Address
- 3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
- Address
- 3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Model information
- Model Name(s)
- CK-MB Calibrator CK-MB Control CK-MB
- Model Identifier(s)
- 6K25-10 6K25-20 6K25-30
About this record
Access comprehensive regulatory information for Sentinel Diagnostics CK-MB 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 DE0012240 and owned by Sentinel CH. SpA. The device was registered on January 31, 2013.
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