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Ortho-Clinical Resolveยฎ Panel B - HSA Registration DE0507646

Access comprehensive regulatory information for Ortho-Clinical Resolveยฎ Panel B 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 DE0507646 and owned by Ortho-Clinical Diagnostics. The device was registered on January 03, 2023.

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
DE0507646
Ortho-Clinical Resolveยฎ Panel B
HSA Registration Number: DE0507646
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Product Description

Qualitative test to detect and/or identify unexpected blood group antibodies.

Device Classification
Device Class
CLASS D IVD
Medical Speciality Area
Hematology
Registration Information
Registration Number
DE0507646
Registration Date
January 03, 2023
Change Notification Approval Date
November 06, 2024
Retention Due Date
January 02, 2026
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)
Resolve Panel B
Model Identifier(s)
6901866