Medical Device Division · registration 220250ActiveBiosensors
Hong KongStents, Vascular, Coronary, Balloon-Expandable, Drug-ElutingClass IVBiosensors Europe SA
Official record identity
- MDACS listing number
- 220250
- Model name
- BioFreedom Ultra Drug Coated Coronary Stent System (BFC1-2209, BFC1-2214, BFC1-2219, BFC1-2224, BFC1-2229, BFC1-2509, BFC1-2514, BFC1-2519, BFC1-2524, BFC1-2529, BFC1-2533, BFC1-2536, BFC1-2709, BFC1-2714, BFC1-2719, BFC1-2724, BFC1-2729, BFC1-2733, BFC1-2736, BFC1-3009, BFC1-3014, BFC1-3019, BFC1-3024, BFC1-3029, BFC1-3033, BFC1-3036, BFC1-3509, BFC1-3514, BFC1-3519, BFC1-3524, BFC1-3529, BFC1-3533, BFC1-3536, BFC1-4009, BFC1-4014, BFC1-4019, BFC1-4024, BFC1-4029)
- Registration date
- August 31, 2022
- Expiry date
- August 31, 2027
- Source update date
- July 22, 2025
- Status
- Active
Official value: Valid
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
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.