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Smith & Nephew ULTRABRACE Kit - HSA Registration DE0510656

Access comprehensive regulatory information for Smith & Nephew ULTRABRACE 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 DE0510656 and owned by Smith & Nephew Inc. Endoscopy. The device was registered on April 30, 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
DE0510656
Smith & Nephew ULTRABRACE Kit
HSA Registration Number: DE0510656
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Product Description

The ULTRABRACEโ„ข Kit is only intended for the reattachment of soft tissue to bone for the following indications: Foot and Ankle โ€ข Medial or lateral instability repairs/reconstructions

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0510656
Registration Date
April 30, 2025
Retention Due Date
April 29, 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)
ULTRABRACE KIT FOOTPRINT MINI PK 3.5MM FOOTPRINT MINI DRILL 3.5MM Q-FIX ULTRA Q-FIX ULTRA CANNULATED DRILL, 2.9MM & 1.25MM DRILL PIN EXTREMITIES GUIDE UNIVERSAL FOOTPRINT MINI DRILL 3.7MM
Model Identifier(s)
72205500 72205687 72205688 72205693 72205694 72205699 72205888