Pure Global

Fresenius AquaC Uno H Reverse Osmosis System - HSA Registration DE0018123

Access comprehensive regulatory information for Fresenius AquaC Uno H Reverse Osmosis System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0018123 and owned by Fresenius Medical Care AG. The device was registered on May 13, 2016.

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 C
DE0018123
Fresenius AquaC Uno H Reverse Osmosis System
HSA Registration Number: DE0018123
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The AquaC reverse osmosis system, which can be cleaned using heat, is an in-house production unit for making permeate to be supplied directly to a hemodialysis device. A booster pump, a membrane module, and appropriate monitoring equipment (conductivity cell) are used to produce permeate from drinking water.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0018123
Registration Date
May 13, 2016
Change Notification Approval Date
May 02, 2024
Retention Due Date
May 12, 2025
Product Owner
Short Name
Fresenius Medical Care AG
Address
Else-Kroner-Str. 1, 61352 Bad Homburg, GERMANY
Registrant
Address
250 NORTH BRIDGE ROAD, RAFFLES CITY TOWER, #05-01, SINGAPORE 179101
Importer
Address
250 NORTH BRIDGE ROAD, RAFFLES CITY TOWER, #05-01, SINGAPORE 179101
Model Information
Model Name(s)
AquaC Uno H
Model Identifier(s)
F00002272