Medical Device Division · registration 220093ActiveBiotronik
Hong KongCatheters, Vascular, Angioplasty, Balloon, Coronary, Drug DeliveryClass IVBiotronik AG
Official record identity
- MDACS listing number
- 220093
- Model name
- Pantera Lux Paclitaxel Releasing PTCA Balloon Catheter (365110, 365120, 365125, 365130, 365135, 365111, 365121, 365126, 365131, 365136, 365112, 365122, 365127, 365132, 365137, 365113, 365123, 365128, 365133, 365138, 365114, 365124, 365129, 365134, 365139)
- Registration date
- April 02, 2026
- Expiry date
- March 14, 2027
- Source update date
- June 15, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
- Published category
- Catheters, Vascular, Angioplasty, Balloon, Coronary, Drug Delivery
Official value: IV
Published parties
- Registrant / registration holder
- Teleflex Medical Hong Kong Limited
- Manufacturer
- Biotronik AG
Official description
Catheters, Vascular, Angioplasty, Balloon, Coronary, Drug Delivery
Additional source fields
- AMD nomenclature code
- 18645
- Local responsible person phone
- 62916211
- Published manufacturer address
- Ackerstrasse 6, 8180 Bulach, Switzerland
- Revision number
- b
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.