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Ekona Gmbh Spol. S R.O.

✅ Low Risk

FEI: 3005783375 • Krasno Nad Becvou, Zlinsky • CZECH REPUBLIC

FEI

FEI Number

3005783375

📍

Location

Krasno Nad Becvou, Zlinsky

🇨🇿
🏢

Address

Na Mlynarce 103/1, , Krasno Nad Becvou, Zlinsky, Czech Republic

Low Risk

FDA Import Risk Assessment

23.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

2
Total Refusals
2
Unique Violations
5/13/2009
Latest Refusal
5/13/2009
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

1182×

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).

3412×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
5/13/2009
78MOAANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)
118NOT LISTED
341REGISTERED
New York District Office (NYK-DO)
5/13/2009
78FDFCOLONOSCOPE, GASTRO-UROLOGY
118NOT LISTED
341REGISTERED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Ekona Gmbh Spol. S R.O.'s FDA import refusal history?

Ekona Gmbh Spol. S R.O. (FEI: 3005783375) has 2 FDA import refusal record(s) in our database, spanning from 5/13/2009 to 5/13/2009.

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. Ekona Gmbh Spol. S R.O.'s FEI number is 3005783375.

What types of violations has Ekona Gmbh Spol. S R.O. received?

Ekona Gmbh Spol. S R.O. 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 Ekona Gmbh Spol. S R.O. come from?

All FDA import refusal data for Ekona Gmbh Spol. S R.O. 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.