Medical Device Division · registration 230441ActiveSino Medical Sciences Technology
Hong KongCatheters, Vascular, Angioplasty, Balloon, CoronaryClass IVSino Medical Sciences Technology Inc.
Official record identity
- MDACS listing number
- 230441
- Model name
- NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter (NCP-2.00-08-RX, NCP-2.00-12-RX, NCP-2.00-15-RX, NCP-2.00-20-RX, NCP-2.25-08-RX, NCP-2.25-12-RX, NCP-2.25-15-RX, NCP-2.25-20-RX, NCP-2.50-08-RX, NCP-2.50-12-RX, NCP-2.50-15-RX, NCP-2.50-20-RX, NCP-2.75-08-RX, NCP-2.75-12-RX, NCP-2.75-15-RX, NCP-2.75-20-RX, NCP-3.00-08-RX, NCP-3.00-12-RX, NCP-3.00-15-RX, NCP-3.00-20-RX, NCP-3.25-08-RX, NCP-3.25-12-RX, NCP-3.25-15-RX, NCP-3.25-20-RX, NCP-3.50-08-RX, NCP-3.50-12-RX, NCP-3.50-15-RX, NCP-3.50-20-RX, NCP-3.75-08-RX, NCP-3.75-12-RX, NCP-3.75-15-RX, NCP-3.75-20-RX, NCP-4.00-08-RX, NCP-4.00-12-RX, NCP-4.00-15-RX, NCP-4.00-20-RX, NCP-4.50-08-RX, NCP-4.50-12-RX, NCP-4.50-15-RX, NCP-4.50-20-RX, NCP-5.00-08-RX, NCP-5.00-12-RX, NCP-5.00-15-RX, NCP-5.00-20-RX)
- Registration date
- November 27, 2023
- Expiry date
- November 27, 2028
- Source update date
- September 17, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
Official value: IV
Published parties
- Registrant / registration holder
- Prism Technologies Limited
- Manufacturer
- Sino Medical Sciences Technology Inc.
Official description
Catheters, Vascular, Angioplasty, Balloon, Coronary
Additional source fields
- AMD nomenclature code
- 34313
- Traditional Chinese local responsible person
- 稜科有限公司
- Local responsible person phone
- 27863233
- Published manufacturer address
- 2nd Floor, TEDA Biopharm Res. Building B, #5 4th St. TEDA, Tianjin, China
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.