CK Electronic GmbH
⚠️ Moderate Risk
FEI: 3004183804 • Cologne, North Rhine-Westphalia • GERMANY
FEI Number
3004183804
Location
Cologne, North Rhine-Westphalia
Country
GERMANYAddress
Mathias-Bruggen-Str. 91, , Cologne, North Rhine-Westphalia, Germany
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
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
Frequently Asked Questions
What is CK Electronic GmbH's FDA import refusal history?
CK Electronic GmbH (FEI: 3004183804) has 2 FDA import refusal record(s) in our database, spanning from 11/20/2003 to 11/7/2013.
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. CK Electronic GmbH's FEI number is 3004183804.
What types of violations has CK Electronic GmbH received?
CK Electronic GmbH 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 CK Electronic GmbH come from?
All FDA import refusal data for CK Electronic 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.