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Smith & Nephew Q-FIX with Needles - HSA Registration DE0510462

Access comprehensive regulatory information for Smith & Nephew Q-FIX with Needles in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510462 and owned by Smith & Nephew Inc. Endoscopy. The device was registered on March 13, 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
DE0510462
Smith & Nephew Q-FIX with Needles
HSA Registration Number: DE0510462
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Product Description

The Q-FIX All-Suture Anchor with Needles use is only intended for the reattachment of soft tissue to bone for the following indications: Foot and Ankle • Medial or lateral instability repairs/reconstructions • Achilles tendon repairs/reconstructions

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0510462
Registration Date
March 13, 2025
Retention Due Date
March 12, 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)
Q-FIX WITH NEEDLES #0 SUTURE DRILL FOR Q-FIX WITH NEEDLES Q-FIX WITH NEEDLES MINITAPE
Model Identifier(s)
72205691 72205692 72205695