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Tactra - SFDA Registration ME0000000537SFDAA00402

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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Class II
ME0000000537SFDAA00402
Tactra
SFDA Registration: ME0000000537SFDAA00402
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Product Information

Penile Implant

Product Use

The Tactraโ„ข 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
Model Information
Model ID(s)
720080-01 720081-01 720082-01
Product Accessories

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