Pure Global

Atellica IM cPSA QC - SFDA Registration ME0000001435SFDAA00958

Access comprehensive regulatory information for Atellica IM cPSA QC in the Saudi Arabia medical device market through Pure Global AI's free database. This Annex II List B device is registered with Saudi Arabia SFDA under registration number ME0000001435SFDAA00958 and manufactured by Siemens Healthcare diagnostics Inc.

This page provides complete registration details including product category (Chemicals), manufacturer information, model details, and regulatory compliance data from the official Saudi Arabia SFDA medical device database. Pure Global AI offers free access to Saudi Arabia's complete medical device registry, helping global MedTech companies navigate SFDA regulations efficiently.

Free Database
Powered by Pure Global AI
SFDA Official Data
Annex II List B
ME0000001435SFDAA00958
Atellica IM cPSA QC
SFDA Registration: ME0000001435SFDAA00958
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Information

Quality control for complexed prostate-specific antigen assay

Product Use

The Atellicaโ„ข IM Complexed Prostateโ€‘Specific Antigen Quality Control (cPSA QC) is for in vitro diagnostic use in monitoring the precision and the accuracy of the Atellica IM cPSA assay using the Atellicaโ„ข IM Analyzer.

Device Classification
Risk Class
Annex II List B
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000001435SFDAA00958
Authorization ID
GHTF-2017-0252
Status
Active
Expire Date
December 31, 2019
Manufacturer
Model Information
Model ID(s)
10995547
Product Accessories

[]