Medical Device Division · registration 140050ActiveBiosensors
Hong KongStents, Vascular, Coronary, Balloon-Expandable, Drug-ElutingClass IVBiosensors Europe SA
Official record identity
- MDACS listing number
- 140050
- Model name
- BioFreedom Drug Coated Coronary Stent System (BFR1-2208, BFR1-2211, BFR1-2214, BFR1-2218, BFR1-2224, BFR1-2228, BFR1-2508, BFR1-2511, BFR1-2514, BFR1-2518, BFR1-2524, BFR1-2528, BFR1-2533, BFR1-2536, BFR1-2708, BFR1-2711, BFR1-2714, BFR1-2718, BFR1-2724, BFR1-2728, BFR1-2733, BFR1-2736, BFR1-3008, BFR1-3011, BFR1-3014, BFR1-3018, BFR1-3024, BFR1-3028, BFR1-3033, BFR1-3036, BFR1-3508, BFR1-3511, BFR1-3514, BFR1-3518, BFR1-3524, BFR1-3528, BFR1-3533, BFR1-3536, BFR1-4008, BFR1-4011, BFR1-4014, BFR1-4018, BFR1-4024, BFR1-4028, BFR1-2542, BFR1-2548, BFR1-2742, BFR1-2748, BFR1-3042, BFR1-3048, BFR1-3542, BFR1-3548)
- Registration date
- December 08, 2023
- Expiry date
- February 26, 2029
- Source update date
- July 09, 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
- Revision number
- d
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.