Medical Device Division · registration 120195ExpiredBiosensors
Hong KongStents, Vascular, Coronary, Balloon-Expandable, Drug-ElutingClass IVBiosensors Europe SA
Official record identity
- MDACS listing number
- 120195
- Model name
- Axxess Drug Eluting Coronary Artery Bifurcation Stent System and Stent Delivery System (AXBF-3011, AXBF-3014, AXBF-3511, AXBF-3514, AXBF-4009)
- Registration date
- June 15, 2012
- Expiry date
- June 15, 2017
- 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
- Pacific Medical (Hong Kong) Company Limited
- Manufacturer
- Biosensors Europe SA
Official description
Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting
Additional source fields
- AMD nomenclature code
- 20383
- Local responsible person phone
- 23438009
- Published manufacturer address
- Rue de Lausanne 29, 1110 Morges, Switzerland
- 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.