Medical Device Division · registration 140438ExpiredTerumo
Hong KongStents, Vascular, Coronary, Balloon-Expandable, Drug-ElutingClass IVTerumo Europe N.V.
Official record identity
- MDACS listing number
- 140438
- Model name
- Ultimaster Sirolimus eluting coronary stent system (DE-RD2209KSM, DE-RD2212KSM, DE-RD2215KSM, DE-RD2218KSM, DE-RD2224KSM, DE-RD2228KSM, DE-RD2233KSM, DE-RD2238KSM, DE-RD2509KSM, DE-RD2512KSM, DE-RD2515KSM, DE-RD2518KSM, DE-RD2524KSM, DE-RD2528KSM, DE-RD2533KSM, DE-RD2538KSM, DE-RD2709KSM, DE-RD2712KSM, DE-RD2715KSM, DE-RD2718KSM, DE-RD2724KSM, DE-RD2728KSM, DE-RD2733KSM, DE-RD2738KSM, DE-RD3009KSM, DE-RD3012KSM, DE-RD3015KSM, DE-RD3018KSM, DE-RD3024KSM, DE-RD3028KSM, DE-RD3033KSM, DE-RD3038KSM, DE-RD3509KSM, DE-RD3512KSM, DE-RD3515KSM, DE-RD3518KSM, DE-RD3524KSM, DE-RD3528KSM, DE-RD3533KSM, DE-RD3538KSM, DE-RD4009KSM, DE-RD4012KSM, DE-RD4015KSM, DE-RD4018KSM, DE-RD4024KSM, DE-RD4028KSM, DE-RD4033KSM, DE-RD4038KSM)
- Registration date
- May 27, 2020
- Expiry date
- February 12, 2025
- Source update date
- October 10, 2024
- Status
- Expired
Classification
- Risk class
- Class IV
- Published category
- Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting
Official value: IV
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
- Interleuvenlaan 40, 3001 Leuven, Belgium
- Published remarks
- Expired.
- 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.