Medical Device Division · registration 180359Active

Terumo Europe

Name: Terumo Europe — Medical Device Division 180359
Creator: Terumo Europe N.V.
Keywords: Terumo Europe, Terumo Europe, 180359, Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting, Medical Device Division

Hong KongStents, Vascular, Coronary, Balloon-Expandable, Drug-ElutingClass IVTerumo Europe N.V.

Verified

Official record identity

MDACS listing number: 180359
Model name: Ultimaster Tansei (DE-RQ2209KSM, DE-RQ2212KSM, DE-RQ2215KSM, DE-RQ2218KSM, DE-RQ2221KSM, DE-RQ2224KSM, DE-RQ2228KSM, DE-RQ2233KSM, DE-RQ2238KSM, DE-RQ2509KSM, DE-RQ2512KSM, DE-RQ2515KSM, DE-RQ2518KSM, DE-RQ2521KSM, DE-RQ2524KSM, DE-RQ2528KSM, DE-RQ2533KSM, DE-RQ2538KSM, DE-RQ2709KSM, DE-RQ2712KSM, DE-RQ2715KSM, DE-RQ2718KSM, DE-RQ2721KSM, DE-RQ2724KSM, DE-RQ2728KSM, DE-RQ2733KSM, DE-RQ2738KSM, DE-RQ3009KSM, DE-RQ3012KSM, DE-RQ3015KSM, DE-RQ3018KSM, DE-RQ3021KSM, DE-RQ3024KSM, DE-RQ3028KSM, DE-RQ3033KSM, DE-RQ3038KSM, DE-RQ3509KSM, DE-RQ3512KSM, DE-RQ3515KSM, DE-RQ3518KSM, DE-RQ3521KSM, DE-RQ3524KSM, DE-RQ3528KSM, DE-RQ3533KSM, DE-RQ3538KSM, DE-RQ4009KSM, DE-RQ4012KSM, DE-RQ4015KSM, DE-RQ4018KSM, DE-RQ4021KSM, DE-RQ4024KSM, DE-RQ4028KSM, DE-RQ4033KSM, DE-RQ4038KSM)
Registration date: July 26, 2023
Expiry date: September 22, 2028
Source update date: October 10, 2024
Status: Active

Classification

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

Published parties

Registrant / registration holder: Terumo China (Hong Kong) Limited
Manufacturer: Terumo Europe N.V.

Official description

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

Additional source fields

AMD nomenclature code: 20383
Traditional Chinese local responsible person: 泰爾茂中國(香港)有限公司
Local responsible person phone: 28660811/25663393
Published manufacturer address: lnterleuvenlaan 40, 3001 Leuven, Belgium
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.