Medical Device Division · registration 160372ActiveEdwards Lifesciences
Hong KongMonitors, Physiologic, Cardiac Output, BedsideClass IIIEdwards Lifesciences LLC
Official record identity
- MDACS listing number
- 160372
- Model name
- EV1000 Clinical Platform NI (EV1000NI, EV1000M, EVPMP, PC2K, PC2, EVNIUPG, CSCS, CSCM, CSCL, EVMB1, EVBB1, EVPB1, EVPMPBRKT, EVHRSBP, EVHRS, PC2B, EVRS, EVS1, PC2CCC, EVEC1, EVECL, EVNIPCL3, EVNIPCL12, EVPMAC, EVNIDBAC, EVEC3FT, EVEC12FT)
- Registration date
- November 21, 2022
- Expiry date
- October 13, 2026
- Source update date
- July 07, 2023
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class III
Official value: III
Published parties
- Registrant / registration holder
- Edwards Lifesciences Hong Kong Limited
- Manufacturer
- Edwards Lifesciences LLC
Official description
Monitors, Physiologic, Cardiac Output, Bedside
Additional source fields
- AMD nomenclature code
- 20174
- Local responsible person phone
- 31809428
- Published manufacturer address
- One Edwards Way, Irvine, CA 92614, USA
- Revision number
- d
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.