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Brainclinics Diagnostics Bv

⚠️ Moderate Risk

FEI: 3009383317 • Nijmegen, Gelderland • NETHERLANDS

FEI

FEI Number

3009383317

📍

Location

Nijmegen, Gelderland

🇳🇱
🏢

Address

Bijleveldsingel 34, , Nijmegen, Gelderland, Netherlands

Moderate Risk

FDA Import Risk Assessment

31.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
6/19/2012
Latest Refusal
6/19/2012
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

1184×

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).

Refusal History

DateProductViolationsDivision
6/19/2012
84GWQELECTROENCEPHALOGRAPH
118NOT LISTED
New Orleans District Office (NOL-DO)
6/19/2012
84GWQELECTROENCEPHALOGRAPH
118NOT LISTED
New Orleans District Office (NOL-DO)
6/19/2012
84GWQELECTROENCEPHALOGRAPH
118NOT LISTED
New Orleans District Office (NOL-DO)
6/19/2012
84GWQELECTROENCEPHALOGRAPH
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Brainclinics Diagnostics Bv's FDA import refusal history?

Brainclinics Diagnostics Bv (FEI: 3009383317) has 4 FDA import refusal record(s) in our database, spanning from 6/19/2012 to 6/19/2012.

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. Brainclinics Diagnostics Bv's FEI number is 3009383317.

What types of violations has Brainclinics Diagnostics Bv received?

Brainclinics Diagnostics Bv 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 Brainclinics Diagnostics Bv come from?

All FDA import refusal data for Brainclinics Diagnostics Bv 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.