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S-Rom ZTT Proximal Sleeve - SFDA Registration ME0000003224SFDAA00446

Access comprehensive regulatory information for S-Rom ZTT Proximal Sleeve 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 ME0000003224SFDAA00446 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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SFDA Official Data
Class III
ME0000003224SFDAA00446
S-Rom ZTT Proximal Sleeve
SFDA Registration: ME0000003224SFDAA00446
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Product Information

Modular system for use in total hip replacement

Product Use

use in total hip replacement procedures for patients suffering severe pain.

Device Classification
Risk Class
Class III
Product Category
Medical Device
Product Type
MD
Registration Information
Registration ID
ME0000003224SFDAA00446
Authorization ID
MDMA-1-2019-1849
Status
Active
Expire Date
February 26, 2026
Manufacturer
Manufacturer Name
DePuy Orthopaedics, Inc.
Model Information
Model ID(s)
550501 550502 550503 550504 550505 550506 521463 521465 550513 550514 550515 550516 550520
Product Accessories

[{'tradeName': 'S-ROM EXTRACTOR SLEEVE SPA & ZT', 'description': 'Surgical Instruments\n', 'gmdn': 'NA'}, {'tradeName': 'S-ROM BLADE SLEEVE EXTRACTOR ', 'description': 'Surgical Instruments\n', 'gmdn': 'NA'}, {'tradeName': 'S-ROM SLEEVE INTRODUCER HANDLE', 'description': 'Surgical Instruments\n', 'gmdn': 'NA'}, {'tradeName': 'S-ROM STEM/SLEEVE SEPARATOR', 'description': 'Surgical Instruments\n', 'gmdn': 'NA'}, {'tradeName': 'S-ROMยฎ TRIAL SLEEVE EXTRACTOR', 'description': 'Surgical Instruments\n', 'gmdn': 'NA'}]