Singapore HSA registration DE0505160

Smith & Nephew REGENETEN Bioinductive Implant System

Singapore·CLASS D·Smith & Nephew Inc.·Registered November 20, 2020

Device classification

Device Class: CLASS D
Medical Speciality Area: General & Plastic Surgery

Registration information

Registration Number: DE0505160
Registration Date: November 20, 2020
Change Notification Approval Date: March 20, 2024
Retention Due Date: November 19, 2025

Product description

The REGENETEN Bioinductive Implant system is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. Tendon anchors are indicated for fixation of prosthetic materials to soft tissues in various minimally invasive and open surgical procedures, such as the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The Bone Anchor is intended for fixation of soft tissue grafts, and it is indicated for fixation of soft tissue grafts during rotator cuff repair.

Product Owner

Name: Smith & Nephew Inc.
Short Name: Smith & Nephew Inc.
Address: 150 Minuteman Road, Andover, Massachusetts, 01810-1031, UNITED STATES

Registrant

Name: SMITH & NEPHEW PTE. LIMITED
Address: 29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565

Importer

Name: SMITH & NEPHEW ASIA PACIFIC PTE. LIMITED SMITH & NEPHEW PTE. LIMITED
Address: 29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565 29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565

Model information

Model Name(s): Bone Anchor (1) Tendon Anchors (8) Mini-Open Bioinductive Implant, Medium 20 x 26 mm Mini-Open Bioinductive Implant, Large 25 x 31 mm Tendon Markers (2) Tendon Stabilizing Guide Bone Anchors (3) with Arthroscopic Delivery System Advanced Bioinductive Implant with Arthroscopic Delivery System (1) Medium Bioinductive Implant with Arthroscopic Delivery System (1) Large
Model Identifier(s): 2503-S 2504-1 2999-2 2999-3 4173-1 4402 4403 4565 4566

About this record

Access comprehensive regulatory information for Smith & Nephew REGENETEN Bioinductive Implant System in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0505160 and owned by Smith & Nephew Inc.. The device was registered on November 20, 2020.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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