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S-Rom Femoral Stem Standard - SFDA Registration ME0000003224SFDAA00448

Access comprehensive regulatory information for S-Rom Femoral Stem Standard in the Saudi Arabia medical device market through Pure Global AI's free database. This Class III device is registered with Saudi Arabia SFDA under registration number ME0000003224SFDAA00448 and manufactured by DePuy Orthopaedics, Inc..

This page provides complete registration details including product category (Medical Device), 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 III
ME0000003224SFDAA00448
S-Rom Femoral Stem Standard
SFDA Registration: ME0000003224SFDAA00448
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Product Information

Modular system for use in Total hip Replacement

Product Use

Used for patients suffering severe pain and disability due to structural damage in hip joints.

Device Classification
Risk Class
Class III
Product Category
Medical Device
Product Type
MD
Registration Information
Registration ID
ME0000003224SFDAA00448
Authorization ID
MDMA-1-2019-1849
Status
Active
Expire Date
February 26, 2026
Manufacturer
Manufacturer Name
DePuy Orthopaedics, Inc.
Model Information
Model ID(s)
523206 523207 523208 523291 523191 523292 523192 563516 563517 526676 563624 563626 875970 875971 875972 875973
Product Accessories

[{'tradeName': 'S-Rom Noiles Rotating Hinge Knee Distal FEM AUG Block', 'description': 'Total Knee replacement \n', 'gmdn': 'NA'}]