Cordis Europa Nv
⚠️ Moderate Risk
FEI: 3002806735 • Roden, Drenthe • NETHERLANDS
FEI Number
3002806735
Location
Roden, Drenthe
Country
NETHERLANDSAddress
Oosteinde 8, Postbus 38, Roden, Drenthe, 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
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/4/2011 | 78FGESTENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | New Orleans District Office (NOL-DO) | |
| 8/4/2011 | 78FGESTENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | New Orleans District Office (NOL-DO) | |
| 8/4/2011 | 78FGESTENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | New Orleans District Office (NOL-DO) | |
| 8/4/2011 | 78FGESTENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | New Orleans District Office (NOL-DO) | |
| 8/4/2011 | 78FGESTENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | New Orleans District Office (NOL-DO) | |
| 8/4/2011 | 78FGESTENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | New Orleans District Office (NOL-DO) | |
| 8/4/2011 | 78FGESTENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | New Orleans District Office (NOL-DO) | |
| 8/4/2011 | 78FGESTENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | New Orleans District Office (NOL-DO) | |
| 8/4/2011 | 78FGESTENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | New Orleans District Office (NOL-DO) | |
| 8/4/2011 | 78FGESTENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | New Orleans District Office (NOL-DO) | |
| 8/4/2011 | 78FGESTENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | New Orleans District Office (NOL-DO) | |
| 8/4/2011 | 78FGESTENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | New Orleans District Office (NOL-DO) | |
| 8/4/2011 | 78FGESTENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | New Orleans District Office (NOL-DO) | |
| 8/4/2011 | 78FGESTENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Cordis Europa Nv's FDA import refusal history?
Cordis Europa Nv (FEI: 3002806735) has 14 FDA import refusal record(s) in our database, spanning from 8/4/2011 to 8/4/2011.
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. Cordis Europa Nv's FEI number is 3002806735.
What types of violations has Cordis Europa Nv received?
Cordis Europa Nv 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 Cordis Europa Nv come from?
All FDA import refusal data for Cordis Europa Nv 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.