Medical Device Division · registration 200426ActiveEdwards Lifesciences
Hong KongMonitoring Systems, PhysiologicClass IIIEdwards Lifesciences LLC
Official record identity
- MDACS listing number
- 200426
- Model name
- HemoSphere Advanced Monitoring Platform (HEM1, HEMOXSC100, HEMSGM10, HEMEXPM10, HEMLTECHM10, HEMPSC100), Hemodynamic Monitoring Equipment (70CC2, 9850A, HEMDPT1000, HEMRLSTD1000, HEMBAT10, HEMOXCR1000), Co-set+ Closed Injectate System (93522)
- Registration date
- August 07, 2025
- Expiry date
- December 02, 2030
- 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
Monitoring Systems, Physiologic
Additional source fields
- AMD nomenclature code
- 12636
- 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.