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SCREW - SFDA Registration ME0000011399SFDAA00193

Access comprehensive regulatory information for SCREW in the Saudi Arabia medical device market through Pure Global AI's free database. This Class IIa device is registered with Saudi Arabia SFDA under registration number ME0000011399SFDAA00193 and manufactured by JJGC Indústria e Comércio de Materiais Dentários SA – NEODENT.

This page provides complete registration details including product category (MD), 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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Class IIa
ME0000011399SFDAA00193
SCREW
SFDA Registration: ME0000011399SFDAA00193
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Product Information

Sterile Surgical Instruments

Product Use

The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Device Classification
Risk Class
Class IIa
Product Category
MD
Product Type
MD
Registration Information
Registration ID
ME0000011399SFDAA00193
Authorization ID
GHTF-2019-5545
Status
Active
Expire Date
April 08, 2024
Model Information
Model ID(s)
116.001-ET 116.002-ET 116.003-ET 116.288 116.288-ET 116.005-ET 116.231-ET 116.232-ET 116.188-ET 116.189-ET 116.285-ET 116.285 116.267-ET 116.270-ET 116.284 116.286 116.286-ET
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