Abiomed Europe GmbH

⚠️ Moderate Risk

FEI: 3007904765 • Aachen, North Rhine-Westphalia • GERMANY

FEI

FEI Number

3007904765

📍

Location

Aachen, North Rhine-Westphalia

🇩🇪

Country

GERMANY

🏢

Address

Neuenhofer Weg 3, , Aachen, North Rhine-Westphalia, Germany

Moderate Risk

FDA Import Risk Assessment

41.2

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

12/4/2023

Latest Refusal

6/21/2007

Earliest Refusal

Score Breakdown

Violation Severity

58.9×40%

Refusal Volume

28.8×30%

Recency

43.4×20%

Frequency

3.0×10%

How is this score calculated?

Proprietary Algorithm

40% Violation Severity — AI-assessed (1-10)
30% Refusal Volume — Logarithmic scale
20% Recency — Decays over 5 years
10% Frequency — Refusals per year

Violation Summary

1185×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

5084×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

Date	Product	Violations	Division
12/4/2023	74DWACONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS	118NOT LISTED 508NO 510(K)	Division of Southeast Imports (DSEI)
10/14/2010	74KFMPUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE	118NOT LISTED	New Orleans District Office (NOL-DO)
6/21/2007	74NKQGUIDEWIRE, CATHETER, REPROCESSED	118NOT LISTED 508NO 510(K)	New Orleans District Office (NOL-DO)
6/21/2007	74DYBINTRODUCER, CATHETER	118NOT LISTED 508NO 510(K)	New Orleans District Office (NOL-DO)
6/21/2007	74DWBPUMP BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE	118NOT LISTED 508NO 510(K)	New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Abiomed Europe GmbH's FDA import refusal history?

Abiomed Europe GmbH (FEI: 3007904765) has 5 FDA import refusal record(s) in our database, spanning from 6/21/2007 to 12/4/2023.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Abiomed Europe GmbH's FEI number is 3007904765.

What types of violations has Abiomed Europe GmbH received?

Abiomed Europe GmbH has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Abiomed Europe GmbH come from?

All FDA import refusal data for Abiomed Europe GmbH is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.