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Singapore HSA registration DE0506430

Diamed DiaClon RhD + Phenotype

Singapore flagSingapore·CLASS D IVD·DiaMed GmbH·Registered November 30, 2021
Device classification
Device Class
CLASS D IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0506430
Registration Date
November 30, 2021
Change Notification Approval Date
November 19, 2024
Retention Due Date
November 29, 2025
Product description
The ID-Card ˝DiaClon RhD + Phenotype˝ is intended to be used for blood grouping, to determine the following antigens expressed on human donor and patient Red Blood Cells (RBCs): D (RH1), C (RH2), c (RH4), E (RH3) and e (RH5) of the Rh Blood Group System. The qualitative antigen 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 RhD + Phenotype DiaClon RhD + Phenotype
Model Identifier(s)
2234 2237
About this record

Access comprehensive regulatory information for Diamed DiaClon RhD + Phenotype 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 DE0506430 and owned by DiaMed GmbH. The device was registered on November 30, 2021.

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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