Pure Global

Atellica IM EHIV - SFDA Registration ME0000001435SFDAA01314

Access comprehensive regulatory information for Atellica IM EHIV in the Saudi Arabia medical device market through Pure Global AI's free database. This Annex II List A device is registered with Saudi Arabia SFDA under registration number ME0000001435SFDAA01314 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 A
ME0000001435SFDAA01314
Atellica IM EHIV
SFDA Registration: ME0000001435SFDAA01314
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Information

Qualitative test for antibodies to human immunodeficiency virus type 1, O, 2 in serum & plasma

Product Use

The Atellicaโ„ข IM HIV 1/O/2 Enhanced (EHIV) assay is for in vitro diagnostic use in the qualitative determination of antibodies to human immunodeficiency virus type 1, including subtype O, and/or type 2 in human serum and plasma (EDTA, lithium heparin, and sodium heparin) using the Atellicaโ„ข IM Analyzer.

Device Classification
Risk Class
Annex II List A
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000001435SFDAA01314
Authorization ID
GHTF-2019-0422
Status
Active
Expire Date
December 31, 2019
Manufacturer
Model Information
Model ID(s)
10995610
Product Accessories

[]