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Sentinel Diagnostics Pancreatic Amylase Assay (LN 6K22 and 6K30) - HSA Registration DE0012244

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.

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CLASS B IVD
DE0012244
Sentinel Diagnostics Pancreatic Amylase Assay (LN 6K22 and 6K30)
HSA Registration Number: DE0012244
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Product Description

Enzymatic colorimetric determination of pancreatic amylase [AmyP] according to the IFCC mod. recommendations in serum and plasma

Device 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 Owner
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