Demenego s.r.l.
⚠️ Moderate Risk
FEI: 1000155401 • Calalzo Di Cadore, Belluno • ITALY
FEI Number
1000155401
Location
Calalzo Di Cadore, Belluno
Country
ITALYAddress
Via Nazionale 49, , Calalzo Di Cadore, Belluno, Italy
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).
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
Refusal History
Frequently Asked Questions
What is Demenego s.r.l.'s FDA import refusal history?
Demenego s.r.l. (FEI: 1000155401) has 1 FDA import refusal record(s) in our database, spanning from 6/1/2005 to 6/1/2005.
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. Demenego s.r.l.'s FEI number is 1000155401.
What types of violations has Demenego s.r.l. received?
Demenego s.r.l. 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 Demenego s.r.l. come from?
All FDA import refusal data for Demenego s.r.l. 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.