Saudi Arabia SFDA registration ME0000000537SFDAA00402
Tactra
Saudi Arabia·Medical Device·Boston Scientific Corporation·Class IIActiveProduct information
Penile Implant
Product use
The Tactra™ device is designed to provide penile rigidity and
malleability, and the device can be placed in either an erect or
a concealed position.
The Tactra Penile Prosthesis is a sterile, single-use implant that
is intended for use in the treatment of chronic, organic, erectile
dysfunction (impotence) in adult males who are determined to
be suitable candidates for implantation surgery.
Device classification
- Risk Class
- Class II
- Product Category
- Medical Device
- Product Type
- MD
Registration information
- Registration ID
- ME0000000537SFDAA00402
- Authorization ID
- MDMA-1-2019-3477
- Status
- Active
- Expire Date
- October 07, 2025
Manufacturer
- Manufacturer Name
- Boston Scientific Corporation
Model information
- Model ID(s)
- 720080-01 720081-01 720082-01
Product accessories
[]
About this record
Access comprehensive regulatory information for Tactra in the Saudi Arabia medical device market through Pure Global AI's free database. This Class II device is registered with Saudi Arabia SFDA under registration number ME0000000537SFDAA00402 and manufactured by Boston Scientific Corporation.
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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