Saudi Arabia SFDA registration ME0000003118SFDAA00001
GEM Premier 3500
Saudi Arabia·Chemicals·Instrumentation Laboratory Co.·General IVD(Others)ActiveProduct 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 682™ or GEM OPL®, 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
- Manufacturer Name
- Instrumentation Laboratory Co.
Model information
- Model ID(s)
- 00026000000
Product accessories
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About this record
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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