Medical Device Division · registration 160033ActiveHemoteq
Hong KongCatheters, Vascular, Angioplasty, BalloonClass IVHemoteq AG
Official record identity
- MDACS listing number
- 160033
- Model name
- Agent MONORAIL Paclitaxel-Coated PTCA Balloon Catheter (H74939222200810, H74939222201210, H74939222201510, H74939222202010, H74939222203010, H74939222220810, H74939222221210, H74939222221510, H74939222222010, H74939222223010, H74939222250810, H74939222251210, H74939222251510, H74939222252010, H74939222253010, H74939222270810, H74939222271210, H74939222271510, H74939222272010, H74939222273010, H74939222300810, H74939222301210, H74939222301510, H74939222302010, H74939222303010, H74939222320810, H74939222321210, H74939222321510, H74939222322010, H74939222323010, H74939222350810, H74939222351210, H74939222351510, H74939222352010, H74939222353010, H74939222370810, H74939222371210, H74939222371510, H74939222372010, H74939222373010, H74939222400810, H74939222401210, H74939222401510, H74939222402010, H74939222403010)
- Registration date
- August 28, 2025
- Expiry date
- February 04, 2031
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
Official value: IV
Published parties
- Registrant / registration holder
- Boston Scientific Hong Kong Limited
- Manufacturer
- Hemoteq AG
Official description
Catheters, Vascular, Angioplasty, Balloon
Additional source fields
- AMD nomenclature code
- 17184
- Local responsible person phone
- 29607100
- Published manufacturer address
- Adenauerstrasse 15, 52146 Wurselen, Germany
- 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.