Singapore HSA registration DE0503757
Bio-Rad DiaMed IH-QC Modular System
Singapore·CLASS D IVD·DiaMed GmbH·Registered October 22, 2019Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Hematology
Registration information
- Registration Number
- DE0503757
- Registration Date
- October 22, 2019
- Change Notification Approval Date
- September 25, 2023
- Retention Due Date
- October 21, 2025
Product description
IH-QC tubes are intended to control the ID-System manually and/or with instruments for the determination of the ABO system, Rh (RH) system, Kell (KEL) system, and/or further immunohematology tests.
Product Owner
- Name
- DiaMed GmbH
- Short Name
- DiaMed GmbH
- Address
- Route du Pra Rond 23, 1785 Cressier, FR, SWITZERLAND
Registrant
- Address
- 3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Importer
- Address
- 3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Model information
- Model Name(s)
- IH-QC1 IH-QC2 IH-QC3 IH-QC4 IH-QC5 IH-QC6
- Model Identifier(s)
- 009321 009322 009323 009324 009325 009326
About this record
Access comprehensive regulatory information for Bio-Rad DiaMed IH-QC Modular System 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 DE0503757 and owned by DiaMed GmbH. The device was registered on October 22, 2019.
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