Medical Device Division · registration 230374Active

Smith & Nephew

Name: Smith & Nephew — Medical Device Division 230374
Creator: Smith & Nephew Inc., Endoscopy Division
Keywords: Smith & Nephew, Smith & Nephew, 230374, Mesh, Collagen, Medical Device Division

Hong KongMesh, CollagenClass IVSmith & Nephew Inc., Endoscopy Division

Verified

Official record identity

MDACS listing number: 230374
Model name: REGENETEN Bioinductive Implant (4565, 4566, 2999-2, 2999-3, 2504-1, 2503-S, 4403, 4402, 4173-1)
Registration date: October 19, 2023
Expiry date: October 19, 2028
Source update date: August 20, 2026
Status: Active

Classification

Risk class: Class IV
Published category: Mesh, Collagen

Published parties

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

Official description

Mesh, Collagen

Additional source fields

AMD nomenclature code: 24190
Traditional Chinese local responsible person: 施樂輝有限公司
Local responsible person phone: 26487700
Published manufacturer address: 150 Minuteman Rd, Andover, Massachusetts, 01810, USA

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.