Alterface Sa
✅ Low Risk
FEI: 3010484800 • Mount Saint Gulivert, FN • BELGIUM
FEI Number
3010484800
Location
Mount Saint Gulivert, FN
Country
BELGIUMAddress
Axis Tecnology Park Rue Edouard, , Mount Saint Gulivert, FN, Belgium
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
Frequently Asked Questions
What is Alterface Sa's FDA import refusal history?
Alterface Sa (FEI: 3010484800) has 2 FDA import refusal record(s) in our database, spanning from 12/12/2010 to 12/12/2010.
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. Alterface Sa's FEI number is 3010484800.
What types of violations has Alterface Sa received?
Alterface Sa 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 Alterface Sa come from?
All FDA import refusal data for Alterface Sa 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.