Medical Device Division · registration 210313ActiveBiotronik
Hong KongCatheters, Vascular, Angioplasty, Balloon, CoronaryClass IVBiotronik AG
Official record identity
- MDACS listing number
- 210313
- Model name
- Pantera LEO Fast-Exchange PTCA Catheter (366991, 366992, 366993, 366994, 366995, 366996, 366997, 366998, 366999, 367000, 367001, 367002, 367003, 367004, 367005, 367006, 367007, 367008, 367009, 367010, 367011, 367012, 367013, 367014, 367015, 367016, 367017, 367018, 367019, 367020, 367021, 367022, 367023, 367024, 367025, 367026, 367027, 367028, 367029, 367030, 367031, 367032, 367033, 367034, 367035, 367036, 367037, 367038, 367039, 367040, 367041, 367042, 367043, 367044, 367045)
- Registration date
- April 02, 2026
- Expiry date
- September 02, 2031
- Source update date
- June 15, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
Official value: IV
Published parties
- Registrant / registration holder
- Teleflex Medical Hong Kong Limited
- Manufacturer
- Biotronik AG
Official description
Catheters, Vascular, Angioplasty, Balloon, Coronary
Additional source fields
- AMD nomenclature code
- 34313
- Local responsible person phone
- 62916211
- Published manufacturer address
- Ackerstrasse 6, 8180 Bülach, Switzerland
- Revision number
- c
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.