Esaote Europe B.V.
⚠️ Moderate Risk
FEI: 3002807888 • Maastricht, Limburg • NETHERLANDS
FEI Number
3002807888
Location
Maastricht, Limburg
Country
NETHERLANDSAddress
Philipsweg 1, Po Box 1132, Maastricht, Limburg, Netherlands
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
© ImportRefusal.com Original Analysis
Violation Summary
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
Refusal History
Frequently Asked Questions
What is Esaote Europe B.V.'s FDA import refusal history?
Esaote Europe B.V. (FEI: 3002807888) has 2 FDA import refusal record(s) in our database, spanning from 9/23/2008 to 6/11/2012.
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. Esaote Europe B.V.'s FEI number is 3002807888.
What types of violations has Esaote Europe B.V. received?
Esaote Europe B.V. has been cited for 1 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 Esaote Europe B.V. come from?
All FDA import refusal data for Esaote Europe B.V. 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.