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Sekisui Alinity c Direct LDL - HSA Registration DE0501345

Access comprehensive regulatory information for Sekisui Alinity c Direct LDL 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 DE0501345 and owned by Sekisui Diagnostics P.E.I. Inc.. The device was registered on March 09, 2018.

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
DE0501345
Sekisui Alinity c Direct LDL
HSA Registration Number: DE0501345
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Product Description

The Alinity c Direct LDL assay is used for the direct, quantitative determination of low-density lipoprotein (LDL) cholesterol in human serum or plasma on the Alinity c analyzer.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0501345
Registration Date
March 09, 2018
Change Notification Approval Date
May 25, 2023
Retention Due Date
March 08, 2026
Product Owner
Short Name
Sekisui Diagnostics P.E.I. Inc.
Address
70 Watts Ave., Charlottetown, Prince Edward Island, Canada C1E 2B9, CANADA
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)
Alinity c Direct LDL Assay File Alinity c Direct LDL Reagent Kit Alinity c Direct LDL Reagent Kit Alinity c Lipid Multiconstituent Calibrator Kit
Model Identifier(s)
07P71-1A 07P7120 07P7123 09P1403