Saudi Arabia SFDA registration ME0000000537SFDAA00325
Polaris™ Ultra
Saudi Arabia·MD·Boston Scientific Corporation·Class IIbActiveProduct information
Polymeric Ureteral Stent
Product use
The stents are intended to facilitate drainage from the kidney to the bladder
via placement endoscopically or fluoroscopically or during an open surgical
procedure by a trained physician.
Device classification
- Risk Class
- Class IIb
- Product Category
- MD
- Product Type
- MD
Registration information
- Registration ID
- ME0000000537SFDAA00325
- Authorization ID
- GHTF-2019-3183
- Status
- Active
- Expire Date
- February 11, 2024
Manufacturer
- Manufacturer Name
- Boston Scientific Corporation
Model information
- Model ID(s)
- M0061921110 M0061921120 M0061921130 M0061921140 M0061921150 M0061921200 M0061921210 M0061921220 M0061921230 M0061921240 M0061921250 M0061921300 M0061921310 M0061921320 M0061921330 M0061921340 M0061921350 M0061921400 M0061921410 M0061921420 M0061921430 M0061921440 M0061921450 M0061921500 M0061921510 M0061921520 M0061921530 M0061921540 M0061921550
Product accessories
[]
About this record
Access comprehensive regulatory information for Polaris™ Ultra in the Saudi Arabia medical device market through Pure Global AI's free database. This Class IIb device is registered with Saudi Arabia SFDA under registration number ME0000000537SFDAA00325 and manufactured by Boston Scientific Corporation.
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.
Free DatabasePowered by Pure Global AISFDA Official DataClass IIb