Singapore HSA registration DE0012244
Sentinel Diagnostics Pancreatic Amylase Assay (LN 6K22 and 6K30)
Singapore·CLASS B IVD·Sentinel CH. SpA·Registered January 31, 2013Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
- HSA Product Code
- HSAMDB00106
- HS Code
- 38220090
Registration information
- Registration Number
- DE0012244
- Registration Date
- January 31, 2013
- Change Notification Approval Date
- October 06, 2022
- Retention Due Date
- January 30, 2026
Product description
Enzymatic colorimetric determination of pancreatic amylase [AmyP] according to the IFCC mod. recommendations in serum and plasma
Product Owner
- Name
- Sentinel CH. SpA
- Short Name
- Sentinel CH. SpA
- Address
- Via Robert Koch 2, 20152 MILANO, 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)
- Pancreatic Amylase Clin Chem Cal Clin Chem Control 1 Clin Chem Control 2
- Model Identifier(s)
- 6K22-30 6K30-10 6K30-20 6K30-21
About this record
Access comprehensive regulatory information for Sentinel Diagnostics Pancreatic Amylase Assay (LN 6K22 and 6K30) 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 DE0012244 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 B IVD