Medical Device Division · registration 240371ActiveAbbott Medical
Hong KongDefibrillator/Cardioverter/Pacemakers, ImplantableClass IVAbbott Medical
Official record identity
- MDACS listing number
- 240371
- Model name
- Fortify Assura VR (CD1359-40C, CD1359-40QC), Fortify Assura DR (CD2359-40C, CD2359-40QC), Ellipse VR (CD1377-36C, CD1377-36QC), Ellipse DR (CD2377-36C, CD2377-36QC)
- Registration date
- September 11, 2024
- Expiry date
- September 10, 2029
- Source update date
- May 08, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
Official value: IV
Published parties
- Registrant / registration holder
- Abbott Medical (Hong Kong) Limited
- Manufacturer
- Abbott Medical
Official description
Defibrillator/Cardioverter/Pacemakers, Implantable
Additional source fields
- AMD nomenclature code
- 18504
- Traditional Chinese local responsible person
- 美國雅培醫療用品(香港)有限公司
- Local responsible person phone
- 29967688
- Published manufacturer address
- 15900 Valley View Court, Sylmar, CA 91342, USA
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.