Pure Global

Bio-Rad DiaMed IH-QC Modular System - HSA Registration DE0503757

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 Database
Powered by Pure Global AI
HSA Official Data
CLASS D IVD
DE0503757
Bio-Rad DiaMed IH-QC Modular System
HSA Registration Number: DE0503757
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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.

Device 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 Owner
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