HSA · registration DE0510089

Ortho-Clinical Affirmagen

Name: Ortho-Clinical Affirmagen — HSA DE0510089
Creator: Ortho-Clinical Diagnostics
Keywords: Ortho-Clinical Affirmagen, Ortho-Clinical Affirmagen, DE0510089, Hematology, HSA

SingaporeHematologyClass DOrtho-Clinical Diagnostics

Verified

Official record identity

Registration number: DE0510089
Model name: Affirmagen; Affirmagen 4
Model identifier: 6901861; 719220
Registration date: November 28, 2024

Classification

Risk class: Class D
Published category: Hematology

Published parties

Product owner: Ortho-Clinical Diagnostics
Registrant / registration holder: ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD.

Official description

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

Additional source fields

Product owner address: Felindre Meadows, Pencoed, Bridgend, CF35 5PZ, United Kingdom
Registrant address: 1 INTERNATIONAL BUSINESS PARK, #01-12, THE SYNERGY, Singapore 609917

About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.