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Ortho-Clinical Diagnostics Ortho Coombs Control - HSA Registration DE0505240

Access comprehensive regulatory information for Ortho-Clinical Diagnostics Ortho Coombs Control 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 DE0505240 and owned by Ortho-Clinical Diagnostics. The device was registered on December 11, 2020.

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
DE0505240
Ortho-Clinical Diagnostics Ortho Coombs Control
HSA Registration Number: DE0505240
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Product Description

Qualitative test to confirm the validity of negative antiglobulin tests.

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Hematology
Registration Information
Registration Number
DE0505240
Registration Date
December 11, 2020
Retention Due Date
December 10, 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)
Ortho Coombs Control
Model Identifier(s)
6901868