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Immucor immuClone Anti-H IgM - HSA Registration DE0510211

Access comprehensive regulatory information for Immucor immuClone Anti-H IgM 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 DE0510211 and owned by Immucor Medizinische Diagnostik GmbH. The device was registered on January 06, 2025.

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 C IVD
DE0510211
Immucor immuClone Anti-H IgM
HSA Registration Number: DE0510211
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Product Description

immuCloneยฎ Anti-H IgM is an in vitro diagnostic Blood Grouping Reagent used to detect the H blood group antigens on human red blood cells from donors and recipients by indirect hemagglutination test for the purpose of a blood transfusion to ensure the safety and compatibility between the patient and the blood component selected for transfusion. immuCloneยฎ Anti-H IgM is intended for Manual Saline Tube Tests (qualitative).

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Hematology
Registration Information
Registration Number
DE0510211
Registration Date
January 06, 2025
Retention Due Date
January 05, 2026
Product Owner
Short Name
Immucor Medizinische Diagnostik GmbH
Address
Robert-Bosch-Strasse 32, DREIEICH, 63303, Germany, GERMANY
Registrant
Address
18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Importer
Address
18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Model Information
Model Name(s)
immuCloneยฎ Anti-H IgM
Model Identifier(s)
9525