BALT Extrusion SAS
⚠️ Moderate Risk
FEI: 3004216185 • Montmorency, Val d oise • FRANCE
FEI Number
3004216185
Location
Montmorency, Val d oise
Country
FRANCEAddress
10 Rue De La Croix Vigneron, Montmorency, , Montmorency, Val d oise, 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
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).
3905
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 |
|---|---|---|---|
| 6/7/2024 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | Division of Southeast Imports (DSEI) | |
| 6/7/2024 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | Division of Southeast Imports (DSEI) | |
| 6/7/2024 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | Division of Southeast Imports (DSEI) | |
| 6/7/2024 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | Division of Southeast Imports (DSEI) | |
| 6/7/2024 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | Division of Southeast Imports (DSEI) | |
| 6/7/2024 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | Division of Southeast Imports (DSEI) | |
| 6/7/2024 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | Division of Southeast Imports (DSEI) | |
| 7/31/2009 | 84LJACATHETER, STEERABLE CEREBROVASCULAR | 508NO 510(K) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is BALT Extrusion SAS's FDA import refusal history?
BALT Extrusion SAS (FEI: 3004216185) has 8 FDA import refusal record(s) in our database, spanning from 7/31/2009 to 6/7/2024.
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. BALT Extrusion SAS's FEI number is 3004216185.
What types of violations has BALT Extrusion SAS received?
BALT Extrusion SAS has been cited for 3 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 BALT Extrusion SAS come from?
All FDA import refusal data for BALT Extrusion SAS 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.