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Ortho-Clinical Affirmagen - HSA Registration DE0510089

Access comprehensive regulatory information for Ortho-Clinical Affirmagen in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0510089 and owned by Ortho-Clinical Diagnostics. The device was registered on November 28, 2024.

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 D IVD
DE0510089
Ortho-Clinical Affirmagen
HSA Registration Number: DE0510089
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Product Description

For in vitro diagnostic use. To confirm the ABO forward (red cell) group.

Device Classification
Device Class
CLASS D IVD
Medical Speciality Area
Hematology
Registration Information
Registration Number
DE0510089
Registration Date
November 28, 2024
Retention Due Date
November 27, 2025
Product Owner
Short Name
Ortho-Clinical Diagnostics
Address
Felindre Meadows, Pencoed, Bridgend, CF35 5PZ, UNITED KINGDOM
Registrant
Address
1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Importer
Address
1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Model Information
Model Name(s)
Affirmagen Affirmagen 4
Model Identifier(s)
6901861 719220