Medical Device Division · registration 160428Expired

Elixir Medical

Name: Elixir Medical — Medical Device Division 160428
Creator: Elixir Medical Corporation
Keywords: Elixir Medical, Elixir Medical, 160428, 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: 160428
Model name: DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System (SPR2514, SPR2518, SPR2523, SPR2528, SPR2714, SPR2718, SPR2723, SPR2728, SPR3014, SPR3018, SPR3023, SPR3028, SPR3214, SPR3218, SPR3223, SPR3228, SPR3514, SPR3518, SPR3523, SPR3528), DESolve XL Novolimus Eluting Bioresorbable Coronary Scaffold System (SPR3714, SPR3718, SPR3723, SPR3728, SPR4014, SPR4018, SPR4023, SPR4028), DESolve Cx Novolimus Eluting Bioresorbable Coronary Scaffold System (SVR2514, SVR2518, SVR2523, SVR2528, SVR2714, SVR2718, SVR2723, SVR2728, SVR3014, SVR3018, SVR3023, SVR3028, SVR3214, SVR3218, SVR3223, SVR3228, SVR3514, SVR3518, SVR3523, SVR3528), DESolve Cx Plus Novolimus Eluting Bioresorbable Coronary Scaffold System (BFR2514, BFR2518, BFR2523, BFR2528, BFR2714, BFR2718, BFR2723, BFR2728, BFR3014, BFR3018, BFR3023, BFR3028, BFR3214, BFR3218, BFR3223, BFR3228, BFR3514, BFR3518, BFR3523, BFR3528)
Registration date: September 22, 2017
Expiry date: December 13, 2021
Source update date: June 25, 2018
Status: Expired

Classification

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

Published parties

Registrant / registration holder: Emergo Hong Kong Limited
Manufacturer: Elixir Medical Corporation

Official description

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

Additional source fields

AMD nomenclature code: 20383
Traditional Chinese local responsible person: 埃默高香港有限公司
Local responsible person phone: 22769196
Published manufacturer address: 920 N. McCarthy Boulevard, Suite 100, Milpitas, California 95035, USA
Published remarks: Expired.
Revision number: a

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.