Medical Device Division · registration 230275Active

Abiomed

Name: Abiomed — Medical Device Division 230275
Creator: Abiomed, Inc.
Keywords: Abiomed, Abiomed, 230275, Catheter Introducers, Medical Device Division

Hong KongCatheter IntroducersClass IIAbiomed, Inc.

Verified

Official record identity

MDACS listing number: 230275
Model name: Impella CP Introducer Kit (0052-3046, 0052-3053, 0052-3052, 0052-0038, 0052-0039)
Registration date: August 24, 2023
Expiry date: August 24, 2028
Source update date: February 21, 2024
Status: Active

Classification

Risk class: Class II
Published category: Catheter Introducers

Published parties

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

Official description

Catheter Introducers

Additional source fields

AMD nomenclature code: 34021
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.