Medical Device Division · registration 210434Active

Abiomed

Name: Abiomed — Medical Device Division 210434
Creator: Abiomed, Inc.
Keywords: Abiomed, Abiomed, 210434, Circulatory Assist Units, Cardiac, Ventricular, Medical Device Division

Hong KongCirculatory Assist Units, Cardiac, VentricularClass IVAbiomed, Inc.

Verified

Official record identity

MDACS listing number: 210434
Model name: Impella 5.0 (0046-3114), Silicon Plug (0046-3028), Impella Guidewire 0.018 (0052-3005), Impella Purge Cassette (0043-0009), Connector Cable Pump/Impella Controller (0042-0002)
Registration date: January 17, 2022
Expiry date: January 17, 2027
Source update date: February 26, 2024
Status: Active

Classification

Risk class: Class IV
Published category: Circulatory Assist Units, Cardiac, Ventricular

Published parties

Registrant / registration holder: DCH Auriga (Hong Kong) Limited
Manufacturer: Abiomed, Inc.

Official description

Circulatory Assist Units, Cardiac, Ventricular

Additional source fields

AMD nomenclature code: 10847
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 01923, United States of America

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.