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Singapore HSA registration DE0014368

Diagast AGH Maestria IgG, C3D

Singapore flagSingapore·CLASS C IVD·Diagast·Registered November 25, 2013
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Hematology
HSA Product Code
Refer to HPR, CWC, LCS, PHU, BSB
HS Code
30029000
Registration information
Registration Number
DE0014368
Registration Date
November 25, 2013
Retention Due Date
November 24, 2025
Product description
AGH Maestria IgG+C3D and AGH Maestria IgG are used for erythrocyte phenotyping with blood phenotyping reagents, in testing for immune antibodies or in transfusion cross matching requiring an indirect antiglobulin test method. AGH Maestria IgG+C3D, AGH Maestria IgG and AGH Maestria C3D are used in the direct antiglobulin test (direct Coombs' test) on human RBC.
Product Owner
Name
Diagast
Short Name
Diagast
Address
251 avenue Eugene Avinee BP 9, 59374 LOOS CEDEX, FRANCE
Registrant
Name
LABOTECH PTE LTD
Address
300 TAMPINES AVENUE 5, INCOME AT TAMPINES JUNCTION, #09-02, SINGAPORE 529653
Importer
Name
LABOTECH PTE LTD
Address
239B VICTORIA STREET, SINGAPORE 188029
Model information
Model Name(s)
AGH Maestria C3D AGH Maestria IGG AGH Maestria IGG+C3D
Model Identifier(s)
76118 76218 76318
About this record

Access comprehensive regulatory information for Diagast AGH Maestria IgG, C3D 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 DE0014368 and owned by Diagast. The device was registered on November 25, 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