Medical Device Division · registration 160427Active

Elixir Medical

Name: Elixir Medical — Medical Device Division 160427
Creator: Elixir Medical Corporation
Keywords: Elixir Medical, Elixir Medical, 160427, Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting, Medical Device Division

Hong KongStents, Vascular, Coronary, Balloon-Expandable, Drug-ElutingClass IVElixir Medical Corporation

Verified

Official record identity

MDACS listing number: 160427
Model name: DESyne Novolimus Eluting Coronary Stent System (SER2514, SER2518, SER2523, SER2528, SER2532, SER2538, SER2714, SER2718, SER2723, SER2728, SER2732, SER2738, SER3014, SER3018, SER3023, SER3028, SER3032, SER3038, SER3514, SER3518, SER3523, SER3528, SER3532, SER3538, SER4014, SER4018, SER4023, SER4028, SER4032, SER4038, SZR2514, SZR2518, SZR2523, SZR2528, SZR2532, SZR2538, SZR2714, SZR2718, SZR2723, SZR2728, SZR2732, SZR2738, SZR3014, SZR3018, SZR3023, SZR3028, SZR3032, SZR3038, SZR3514, SZR3518, SZR3523, SZR3528, SZR3532, SZR3538, SZR4014, SZR4018, SZR4023, SZR4028, SZR4032, SZR4038), DESyne X2 Novolimus Eluting Coronary Stent System (SZR2214, SZR2218, SZR2223, SZR2228, SZR2232, SZR2238, SZR2514, SZR2518, SZR2523, SZR2528, SZR2532, SZR2538, SZR2714, SZR2718, SZR2723, SZR2728, SZR2732, SZR2738, SZR3014, SZR3018, SZR3023, SZR3028, SZR3032, SZR3038, SZR3514, SZR3518, SZR3523, SZR3528, SZR3532, SZR3538, SZR4014, SZR4018, SZR4023, SZR4028, SZR4032, SZR4038)
Registration date: August 26, 2026
Expiry date: December 12, 2031
Source update date: September 01, 2026
Status: Active

Classification

Risk class: Class IV
Published category: Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting

Published parties

Registrant / registration holder: Asia Actual Limited
Manufacturer: Elixir Medical Corporation

Official description

Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting

Additional source fields

AMD nomenclature code: 20383
Local responsible person phone: 28933118
Published manufacturer address: 920 N. McCarthy Boulevard, Suite 100, Milpitas, California 95035, USA
Revision number: e

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.