Saudi Arabia SFDA registration ME0000003224SFDAA00446
S-Rom ZTT Proximal Sleeve
Saudi Arabia·Medical Device·DePuy Orthopaedics, Inc.·Class IIIActiveProduct 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-ROM® TRIAL SLEEVE EXTRACTOR', 'description': 'Surgical Instruments\n', 'gmdn': 'NA'}]
About this record
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.
Free DatabasePowered by Pure Global AISFDA Official DataClass III