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Singapore HSA registration DE0510272

Diamed DiaClon ABO/D (DVI+, DVI-) + Reverse Grouping

Singapore flagSingapore·CLASS D IVD·DiaMed GmbH·Registered January 22, 2025
Device classification
Device Class
CLASS D IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0510272
Registration Date
January 22, 2025
Retention Due Date
January 21, 2026
Product description
The ID-Card ˝DiaClon ABO/D (DVI+, DVI-) + Reverse Grouping˝ is intended to be used for blood grouping, to determine the following antigens expressed on human donor and patient Red Blood Cells (RBCs): A (ABO1), B (ABO2) of the ABO Blood Group System (forward grouping) and D (RH1) of the Rh Blood Group System and to determine the presence of anti-A and anti-B in human serum or plasma (reverse grouping). The qualitative determination can be carried out manually or using instruments intended for the ID-System. For in vitro diagnostic use, by trained laboratory personnel.
Product Owner
Name
DiaMed GmbH
Short Name
DiaMed GmbH
Address
Pra Rond 23, 1785 Cressier, FR, Switzerland, SWITZERLAND
Registrant
Name
BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
Address
3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Importer
Name
BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
Address
3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Model information
Model Name(s)
DiaClon ABO/D (DVI+, DVI-) + Reverse Grouping
Model Identifier(s)
1386
About this record

Access comprehensive regulatory information for Diamed DiaClon ABO/D (DVI+, DVI-) + Reverse Grouping 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 DE0510272 and owned by DiaMed GmbH. The device was registered on January 22, 2025.

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