Medical Device Division · registration 210382ActiveAbiomed
Hong KongCatheters, CardiacClass IVAbiomed Inc.
Official record identity
- MDACS listing number
- 210382
- Model name
- Impella 5.5 with Smart Assist (0550-0007, 2000193), Incision Template (0550-3020), Axillary Insertion Graft Lock (0052-3008), Impella Guidewire 0.018 (0052-3005), Impella Purge Cassette (0043-0009, 1000185, 1000200, 2000171), Silicone Plug (0046-3028)
- Registration date
- July 21, 2025
- Expiry date
- December 03, 2026
- Source update date
- July 29, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
Official value: IV
Published parties
- Registrant / registration holder
- DCH Auriga (Hong Kong) Limited
- Manufacturer
- Abiomed Inc.
Official description
Catheters, Cardiac
Additional source fields
- AMD nomenclature code
- 10698
- 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, MA 21923, United States of America
- Published remarks
- Renewal application has been received.
- 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.