Medical Device Division · registration 200427ActiveEdwards Lifesciences
Hong KongTransducers, PressureClass IIEdwards Lifesciences LLC
Official record identity
- MDACS listing number
- 200427
- Model name
- FloTrac Sensor (MHD8, MHD85, MHD6, MHD65, MHD6AZ, MHD6AZ5, MHD8R, MHD8R5, MHD6R, MHD6R5, MHD6AZR, MHD6AZR5), Acumen IQ Sensor (AIQS6, AIQS65, AIQS6AZ, AIQS6AZ5, AIQS6AZA, AIQS6AZR, AIQS6AZR5, AIQS6C502, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8C503, AIQS8R, AIQS8S, AIQS8S102,AIQS6S, AIQS8R5, AIQSAFM8R5)
- Registration date
- August 13, 2025
- Expiry date
- December 02, 2030
- Source update date
- August 14, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class II
Official value: II
Published parties
- Registrant / registration holder
- Edwards Lifesciences Hong Kong Limited
- Manufacturer
- Edwards Lifesciences LLC
Official description
Transducers, Pressure
Additional source fields
- AMD nomenclature code
- 14119
- Local responsible person phone
- 31809428
- Published manufacturer address
- One Edwards Way, Irvine CA 92614, USA
- 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.