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Singapore HSA registration DE0505240

Ortho-Clinical Diagnostics Ortho Coombs Control

Singapore flagSingapore·CLASS C IVD·Ortho-Clinical Diagnostics·Registered December 11, 2020
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 description
Qualitative test to confirm the validity of negative antiglobulin tests.
Product Owner
Name
Ortho-Clinical Diagnostics
Short Name
Ortho-Clinical Diagnostics
Address
Felindre Meadows, Pencoed, Bridgend, CF35 5PZ, UNITED KINGDOM
Registrant
Name
ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD.
Address
1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Importer
Name
ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD.
Address
1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Model information
Model Name(s)
Ortho Coombs Control
Model Identifier(s)
6901868
About this record

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD