Medical Device Division · registration 220168Active

Smith & Nephew

Name: Smith & Nephew — Medical Device Division 220168
Creator: Smith & Nephew Inc.
Keywords: Smith & Nephew, Smith & Nephew, 220168, Suture Units, Automated, Endoscopy, Arthroscope, Medical Device Division

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

Verified

Official record identity

MDACS listing number: 220168
Model name: NOVOCUT Suture Manager (CTX-C001), NOVOSTITCH PRO Meniscal Repair System (2-0) (CTX-A003), NOVOSTITCH PRO Meniscal Repair System (0) (CTX-A004), NOVOSTITCH Cartridge (2-0) (CTX-R001), NOVOSTITCH Cartridge (0) (CTX-R002)
Registration date: August 07, 2025
Expiry date: June 01, 2027
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.

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: Endoscopy, 150 Minuteman Road, Andover, Massachusetts, 01810, 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.