Medical Device Division · registration 120500ActiveBiotronik
Hong KongStents, Vascular, Coronary, Balloon-Expandable, Drug-ElutingClass IVBiotronik AG
Official record identity
- MDACS listing number
- 120500
- Model name
- Orsiro Sirolimus-Eluting Coronary Stent System (364469, 364470, 364471, 364472, 364473, 364474, 364475, 364476, 364477, 364478, 364479, 364480, 364481, 364482, 364483, 364484, 364485, 364486, 364487, 364488, 364489, 364490, 364491, 364492, 364499, 364500, 364501, 364502, 364503, 364504, 364505, 364506, 364507, 364508, 364509, 364510, 364511, 364512, 364513, 364514, 364515, 364516, 391234, 391235, 391236, 391237, 391018, 391019, 391238, 391239, 391240, 391241, 391020, 391021)
- Registration date
- April 29, 2026
- Expiry date
- March 01, 2028
- Source update date
- September 15, 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
- Teleflex Medical Hong Kong Limited
- Manufacturer
- Biotronik AG
Official description
Stents, Vascular, Coronary, Balloon-Expandable, Drug-Eluting
Additional source fields
- AMD nomenclature code
- 20383
- Local responsible person phone
- 62916211
- Published manufacturer address
- Ackerstrasse 6, 8180 Bulach, Switzerland
- Revision number
- e
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.