Medical Device Division · registration 180248ActiveSIS Medical
Hong KongCatheters, Vascular, Angioplasty, Balloon, Coronary, PerfusionClass IVSIS Medical AG
Official record identity
- MDACS listing number
- 180248
- Model name
- OPN NC (150-010-004, 150-015-004, 150-020-004, 200-010-004, 200-015-004, 200-020-004, 250-010-004, 250-015-004, 250-020-004, 300-010-004, 300-015-004, 300-020-004, 350-010-004, 350-015-004, 350-020-004, 400-010-004, 400-015-004, 400-020-004, 450-010-004, 450-015-004, 450-020-004)
- Registration date
- August 08, 2024
- Expiry date
- August 06, 2028
- Source update date
- November 06, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
- Published category
- Catheters, Vascular, Angioplasty, Balloon, Coronary, Perfusion
Official value: IV
Published parties
- Registrant / registration holder
- Pacific Medical (Hong Kong) Company Limited
- Manufacturer
- SIS Medical AG
Official description
Catheters, Vascular, Angioplasty, Balloon, Coronary, Perfusion
Additional source fields
- AMD nomenclature code
- 17521
- Local responsible person phone
- 23438009
- Published manufacturer address
- Hungerbuelstrasse 12a, 8500 Frauenfeld, 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.