Medical Device Division · registration 190233ActiveEdwards Lifesciences
Hong KongProstheses, Cardiac Valve, BiologicalClass IVEdwards Lifesciences LLC
Official record identity
- MDACS listing number
- 190233
- Model name
- EDWARDS INTUITY Elite System Kits (8300KITB19, 8300KITB21, 8300KITB23, 8300KITB25, 8300KITB27, 8300AB 19mm, 8300AB 21mm, 8300AB 23mm, 8300AB 25mm, 8300AB 27mm, 8300DB19, 8300DB21, 8300DB23, 8300DB25, 8300DB27, 96417)
- Registration date
- June 06, 2024
- Expiry date
- July 16, 2029
- Source update date
- April 25, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
Official value: IV
Published parties
- Registrant / registration holder
- Edwards Lifesciences Hong Kong Limited
- Manufacturer
- Edwards Lifesciences LLC
Official description
Prostheses, Cardiac Valve, Biological
Additional source fields
- AMD nomenclature code
- 15870
- 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.