Medical Device Division · registration 240169ActiveMedtronic
Hong KongDefibrillator/Cardioverter/Pacemakers, ImplantableClass IVMedtronic, Inc.
Official record identity
- MDACS listing number
- 240169
- Model name
- Aurora EV-ICD MRI SureScan (DVEA3E4), Epsila EV MRI SureScan (EV240152, EV240163), Epsila EV (EAZ101, EAZ201), Aurora EV-ICD MRI SureScan (SW041)
- Registration date
- May 08, 2024
- Expiry date
- May 07, 2029
- Source update date
- August 29, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
Official value: IV
Published parties
- Registrant / registration holder
- Medtronic Hong Kong Medical Limited
- Manufacturer
- Medtronic, Inc.
Official description
Defibrillator/Cardioverter/Pacemakers, Implantable
Additional source fields
- AMD nomenclature code
- 18504
- Traditional Chinese local responsible person
- 美敦力香港醫療有限公司
- Local responsible person phone
- 29191300
- Published manufacturer address
- 710 Medtronic Parkway, Minneapolis, Minnesota, 55432, 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.