EKF Diagnostic Gmbh
⚠️ Moderate Risk
FEI: 3004838836 • Barleben, Saxony-Anhalt • GERMANY
FEI Number
3004838836
Location
Barleben, Saxony-Anhalt
Country
GERMANYAddress
Barleben/Madgeburg Barleben/Madgeburg Barleben/Madgeburg, Ebendorfer Chaussee 3, Barleben, Saxony-Anhalt, 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
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/24/2012 | 75JJXSINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/24/2012 | 75JJXSINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/24/2012 | 75JJXSINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/24/2012 | 75CGAGLUCOSE OXIDASE, GLUCOSE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is EKF Diagnostic Gmbh's FDA import refusal history?
EKF Diagnostic Gmbh (FEI: 3004838836) has 4 FDA import refusal record(s) in our database, spanning from 5/24/2012 to 5/24/2012.
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. EKF Diagnostic Gmbh's FEI number is 3004838836.
What types of violations has EKF Diagnostic Gmbh received?
EKF Diagnostic 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 EKF Diagnostic Gmbh come from?
All FDA import refusal data for EKF Diagnostic 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.