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ABIOMED EUROPE GMBH — FDA Facility Profile

FEI 3007904765

ABIOMED EUROPE GMBH is an FDA-registered facility (FEI 3007904765) located in Aachen North Rhine-Westphalia, DE. RegDataLab tracks 3 FDA inspections at this facility.

Facility Details

Location
Aachen North Rhine-Westphalia (DE)
Registration Expires
N/A
Operations
Source
device

Recent inspections

  • 1194249 (NAI Thu Nov 10 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 979231 (NAI Thu Jun 23 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 910065 (NAI Thu Dec 18 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • 799-7973240-1/11/1 (Mon Dec 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-7996364-2/1/1 (Thu Oct 14 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-6652000-8/1/1 (Thu Jun 21 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-6652000-8/1/2 (Thu Jun 21 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-6652000-8/2/1 (Thu Jun 21 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources