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Smith & Nephew ULTRABRIDGE Kit - HSA Registration DE0510446

Access comprehensive regulatory information for Smith & Nephew ULTRABRIDGE Kit in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510446 and owned by Smith & Nephew Inc. Endoscopy. The device was registered on March 11, 2025.

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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CLASS C
DE0510446
Smith & Nephew ULTRABRIDGE Kit
HSA Registration Number: DE0510446
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Product Description

The ULTRABRIDGE™ Kit is intended for use only for the reattachment of soft tissue to bone for the following indications: Foot and Ankle • Achilles tendon repairs/reconstructions

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0510446
Registration Date
March 11, 2025
Retention Due Date
March 10, 2026
Product Owner
Short Name
Smith & Nephew Inc. Endoscopy
Address
150 Minuteman Road, Andover, Massachusetts, 01810, UNITED STATES
Registrant
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565
Importer
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565 29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565
Model Information
Model Name(s)
HEALICOIL PK SUTURE ANCHOR WITH NEEDLES ULTRATAPE (BLUE) HEALICOIL PK SUTURE ANCHOR WITH NEEDLES ULTRATAPE (BLUE COBRAID) ULTRABRIDGE DRILL 4.0MM EXTREMITIES GUIDE UNIVERSAL ULTRABRIDGE KIT
Model Identifier(s)
72205696 72205697 72205698 72205699 72205700