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0.8% Affirmagen® 4 - SFDA Registration ME0000004465SFDAA00005

Access comprehensive regulatory information for 0.8% Affirmagen® 4 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 ME0000004465SFDAA00005 and manufactured by Ortho Clinical Diagnostics.

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.

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Annex II List A
ME0000004465SFDAA00005
0.8% Affirmagen® 4
SFDA Registration: ME0000004465SFDAA00005
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Product Information

ABO Grouping Cells

Product Use

For use with Ortho BioVue® System to confirm the ABO forward (red cell) group FOR IN VITRO DIAGNOSTIC USE

Device Classification
Risk Class
Annex II List A
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000004465SFDAA00005
Authorization ID
GHTF-2015-0888
Status
Active
Expire Date
July 08, 2017
Manufacturer
Model Information
Model ID(s)
719221
Product Accessories

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