Medical Device Division · registration 180510ActiveBiotronik
Hong KongStent/Grafts, Vascular, PeripheralClass IIIBiotronik AG
Official record identity
- MDACS listing number
- 180510
- Model name
- PULSAR-35 Peripheral Self-Expanding Nitinol Stent System (379878, 379879, 379880, 379881, 379883, 379884, 379885, 379886, 379888, 379889, 379890, 379891, 379898, 379899, 379900, 379901, 379903, 379904, 379905, 379906, 379908, 379909, 379910, 379911, 379917, 379918, 379919, 379920, 379921, 379922, 379923, 379924, 379925, 379926, 379927, 379928, 379929, 379930, 379931, 379937, 379938, 379939, 379940, 379941, 379942, 379943, 379944, 379945, 379946, 379947, 379948, 379949, 379950, 379951)
- Registration date
- April 02, 2026
- Expiry date
- December 06, 2028
- Source update date
- June 15, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class III
Official value: III
Published parties
- Registrant / registration holder
- Teleflex Medical Hong Kong Limited
- Manufacturer
- Biotronik AG
Official description
Stent/Grafts, Vascular, Peripheral
Additional source fields
- AMD nomenclature code
- 20455
- Local responsible person phone
- 62916211
- Published manufacturer address
- Ackerstrasse 6, Bulach, 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.