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GEM Premier 3500 - SFDA Registration ME0000003118SFDAA00001

Access comprehensive regulatory information for GEM Premier 3500 in the Saudi Arabia medical device market through Pure Global AI's free database. This General IVD(Others) device is registered with Saudi Arabia SFDA under registration number ME0000003118SFDAA00001 and manufactured by Instrumentation Laboratory Co..

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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General IVD(Others)
ME0000003118SFDAA00001
GEM Premier 3500
SFDA Registration: ME0000003118SFDAA00001
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Product Information

Whole blood sample analyzer

Product Use

The GEM Premier 3500 is designed as a portable system for use by health care professionals to rapidly analyze whole blood samples, in any clinical setting. The instrument provides both measured and calculated results for blood gases, hematocrit, electrolytes, glucose, and lactate. The instrument may also be used in conjunction with an external IL CO-Oximeter device, the IL 682โ„ข or GEM OPLยฎ, with CO-Ox results integrated into the GEM Premier 3500 results.

Device Classification
Risk Class
General IVD(Others)
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000003118SFDAA00001
Authorization ID
MDMA-1-2019-1781
Status
Active
Expire Date
May 26, 2027
Manufacturer
Model Information
Model ID(s)
00026000000
Product Accessories

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