Eurosurgical S.A.
⚠️ Moderate Risk
FEI: 3002620729 • Beaurains, Pas de Calais • FRANCE
FEI Number
3002620729
Location
Beaurains, Pas de Calais
Country
FRANCEAddress
18 Rue Robespierre, , Beaurains, Pas de Calais, France
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
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 |
|---|---|---|---|
| 10/3/2002 | 79HXDCLAMP | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 78LBWSET, DIALYSIS, SINGLE NEEDLE (CO-AXIAL FLOW) | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 79GDOAPPLIER, SURGICAL, CLIP | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 87HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 87HWCSCREW, FIXATION, BONE | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 87HTNWASHER, BOLT, NUT | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 10/3/2002 | 79GFGBIT, SURGICAL | 508NO 510(K) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Eurosurgical S.A.'s FDA import refusal history?
Eurosurgical S.A. (FEI: 3002620729) has 7 FDA import refusal record(s) in our database, spanning from 10/3/2002 to 10/3/2002.
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. Eurosurgical S.A.'s FEI number is 3002620729.
What types of violations has Eurosurgical S.A. received?
Eurosurgical S.A. 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 Eurosurgical S.A. come from?
All FDA import refusal data for Eurosurgical S.A. 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.