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Singapore HSA registration DE0504646

Immucor NEO Iris

Singapore flagSingapore·CLASS D IVD·Immucor Medizinische Diagnostik GmbH·Registered June 30, 2020
Device classification
Device Class
CLASS D IVD
Medical Speciality Area
Hematology
Registration information
Registration Number
DE0504646
Registration Date
June 30, 2020
Change Notification Approval Date
December 13, 2024
Retention Due Date
June 29, 2025
Product description
The NEO Iris is a microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. The NEO Iris automates test processing, result interpretation, and data management functions. The NEO Iris is designed to automate standard immunohematology assays using a microplate based platform. Assays include ABO grouping and Rh (D) typing, detection / identification of IgG red blood cell antibodies, compatibility testing, red blood cell phenotyping, antigen screening and infectious disease screening, such as cytomegalovirus (CMV).
Product Owner
Name
Immucor Medizinische Diagnostik GmbH
Short Name
Immucor Medizinische Diagnostik GmbH
Address
Robert-Bosch-Strasse 32, DREIEICH, 63303, Germany, GERMANY
Registrant
Name
BIOMED DIAGNOSTICS PTE LTD
Address
18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Importer
Name
BIOMED DIAGNOSTICS PTE LTD
Address
18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Model information
Model Name(s)
NEO Iris
Model Identifier(s)
64598
About this record

Access comprehensive regulatory information for Immucor NEO Iris 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 DE0504646 and owned by Immucor Medizinische Diagnostik GmbH. The device was registered on June 30, 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 D IVD