Medical Device Division · registration 180162ActiveAbiomed
Hong KongCirculatory Assist Units, CardiacClass IIIAbiomed Inc.
Official record identity
- MDACS listing number
- 180162
- Model name
- Automated Impella Controller (0042-0010), Impella Connect (0042-4100), Automated Impella controller with Impella Connect (0042-0040)
- Registration date
- August 29, 2023
- Expiry date
- June 11, 2028
- Source update date
- April 02, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class III
Official value: III
Published parties
- Registrant / registration holder
- DCH Auriga (Hong Kong) Limited
- Manufacturer
- Abiomed Inc.
Official description
Circulatory Assist Units, Cardiac
Additional source fields
- AMD nomenclature code
- 10840
- Traditional Chinese local responsible person
- 奧利佳(香港)有限公司
- Local responsible person phone
- 36192800
- Published manufacturer address
- 22 Cherry Hill Drive, Danvers, Massachusetts 01923, 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.