Medical Device Division · registration 160441ActiveBiosensors
Hong KongStents, Vascular, Coronary, Balloon-Expandable, Drug-ElutingClass IVBiosensors Europe SA
Official record identity
- MDACS listing number
- 160441
- Model name
- BioMatrix Alpha (BMX6-2209, BMX6-2214, BMX6-2219, BMX6-2224, BMX6-2229, BMX6-2509, BMX6-2514, BMX6-2519, BMX6-2524, BMX6-2529, BMX6-2533, BMX6-2536, BMX6-2709, BMX6-2714, BMX6-2719, BMX6-2724, BMX6-2729, BMX6-2733, BMX6-2736, BMX6-3009, BMX6-3014, BMX6-3019, BMX6-3024, BMX6-3029, BMX6-3033, BMX6-3036, BMX6-3509, BMX6-3514, BMX6-3519, BMX6-3524, BMX6-3529, BMX6-3533, BMX6-3536, BMX6-4009, BMX6-4014, BMX6-4019, BMX6-4024, BMX6-4029)
- Registration date
- September 02, 2021
- Expiry date
- December 19, 2026
- Source update date
- August 14, 2026
- 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 do Lausanne 29, 1110 Morges, Switzerland
- Published remarks
- Renewal application has been received.
- 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.