Remedent, NV
⚠️ Moderate Risk
FEI: 3004018481 • Sint-Martens-Latem, Oost-Vlaanderen • BELGIUM
FEI Number
3004018481
Location
Sint-Martens-Latem, Oost-Vlaanderen
Country
BELGIUMAddress
Xavier De Cocklaan 42, , Sint-Martens-Latem, Oost-Vlaanderen, Belgium
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 Remedent, NV's FDA import refusal history?
Remedent, NV (FEI: 3004018481) has 3 FDA import refusal record(s) in our database, spanning from 5/11/2005 to 11/27/2007.
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. Remedent, NV's FEI number is 3004018481.
What types of violations has Remedent, NV received?
Remedent, NV 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 Remedent, NV come from?
All FDA import refusal data for Remedent, 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.