Pure Global

Siemens Atellica DCA™ Microalbumin/Creatinine - HSA Registration DE0507574

Access comprehensive regulatory information for Siemens Atellica DCA™ Microalbumin/Creatinine in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0507574 and owned by Simens Healthcare Diagnostics Inc.. The device was registered on December 06, 2022.

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 B IVD
DE0507574
Siemens Atellica DCA™ Microalbumin/Creatinine
HSA Registration Number: DE0507574
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

Atellica DCA ACR assay is an in vitro diagnostic test for quantitative determination of albumin, creatinine, and albumin/creatinine ratio (ACR) in human urine. The measurement of urine albumin, creatinine and albumin/ creatinine ratio, aids in the early diagnosis of kidney disease, screening and monitoring of microalbuminuria.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0507574
Registration Date
December 06, 2022
Change Notification Approval Date
November 04, 2024
Retention Due Date
December 05, 2025
Product Owner
Short Name
Siemens Health
Address
511 Benedict Avenue, Tarrytown, New York 10591-5097, New York, UNITED STATES
Registrant
Address
60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Importer
Address
219 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #08-02, SINGAPORE 159556 60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Model Information
Model Name(s)
DCA Systems Microalbumin/Creatinine Control Kit Atellica DCA ACR Reagent Kit Atellica POC Solution Adaptor Ethernet Kit Atellica DCA Analyzer Atellica POC Solution Display Atellica DCA Analyzer ACR Capillary Holders and Plungers Optical Test Cartridge Air filter (2 pack) Cleaning Kit Atellica POC Solution Adaptor Atellica DCA Module
Model Identifier(s)
10325406 (6012A) 10888779 11317926 11419264 11419268 11419359 11420519 11420524 11420525 11538022 11561560