Saudi Arabia SFDA registration ME0000003224SFDAA00445
S-Rom Patella Dome
Saudi Arabia·Medical Device·DePuy Orthopaedics, Inc.·Class IIIActiveProduct information
knee system replacement for both primary and revision cases.
Product use
use with PMMA bone cement in primary or revision cases.
Device classification
- Risk Class
- Class III
- Product Category
- Medical Device
- Product Type
- MD
Registration information
- Registration ID
- ME0000003224SFDAA00445
- Authorization ID
- MDMA-1-2019-1849
- Status
- Active
- Expire Date
- February 26, 2026
Manufacturer
- Manufacturer Name
- DePuy Orthopaedics, Inc.
Model information
- Model ID(s)
- 621630 621632 621635 621638
Product accessories
[]
About this record
Access comprehensive regulatory information for S-Rom Patella Dome 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 ME0000003224SFDAA00445 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