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BN ProSpec System - SFDA Registration ME0000001481SFDAA00381

Access comprehensive regulatory information for BN ProSpec System 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 ME0000001481SFDAA00381 and manufactured by Siemens Healthcare diagnostics products Gmbh.

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)
ME0000001481SFDAA00381
BN ProSpec System
SFDA Registration: ME0000001481SFDAA00381
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Product Information

device for quantitative determination of proteins in serum, plasma and urine

Product Use

"The BN ProSpec provides a quantitative and fully automated determination of plasma proteins by means of ephelometric analysis of serum, plasma, urine and CSF. The instrument is designed for continuous use and has a cooler for reagents and controls (approximately 8*C). Standards must be refrigerated off the instrument immediately after use. The BN ProSpec can perform precipitation and agglutination reactions (latex) quickly and accurately.

Device Classification
Risk Class
General IVD(Others)
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000001481SFDAA00381
Authorization ID
GHTF-2017-1506
Status
Active
Expire Date
December 24, 2019
Model Information
Model ID(s)
OVLI01
Product Accessories

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