Medical Device Division · registration 160006Active

Smith & Nephew

Name: Smith & Nephew — Medical Device Division 160006
Creator: Smith & Nephew, Inc. Endoscopy Division
Keywords: Smith & Nephew, Smith & Nephew, 160006, Suture Units, Automated, Endoscopy, Arthroscope, Medical Device Division

Hong KongSuture Units, Automated, Endoscopy, ArthroscopeClass IIISmith & Nephew, Inc. Endoscopy Division

Verified

Official record identity

MDACS listing number: 160006
Model name: FasT-Fix 360 Straight Needle Delivery System (72202467), FasT-Fix 360 Curved Needle Delivery System (72202468), FasT-Fix 360 Reverse Curve Needle Delivery System (72202469), Knot Pusher/Suture Cutter and Slotted Cannula (72202674), Curved Knot Pusher/Suture Cutter and Slotted Cannula (72202675), T-Fix Depth probe (015186), Diamond Rasp, 45 degree (014549), Diamond Rasp, 90 degree (014550), FasT Fix Slotted Cannula (7210977), (10)Suture Funnel (7210450), (10)Suture Threader (7209950)
Registration date: August 13, 2025
Expiry date: January 31, 2031
Source update date: August 20, 2026
Status: Active

Classification

Risk class: Class III
Published category: Suture Units, Automated, Endoscopy, Arthroscope

Published parties

Registrant / registration holder: Smith & Nephew Limited
Manufacturer: Smith & Nephew, Inc. Endoscopy Division

Official description

Suture Units, Automated, Endoscopy, Arthroscope

Additional source fields

AMD nomenclature code: 17735
Traditional Chinese local responsible person: 施樂輝有限公司
Local responsible person phone: 26487700
Published manufacturer address: 150 Minuteman Road, Andover, Massachusetts, 01810-1031, USA
Revision number: b

About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.