Uvex Sports Gmbh And Co Kg
⚠️ Moderate Risk
FEI: 1000260654 • Furth, Bavaria • GERMANY
FEI Number
1000260654
Location
Furth, Bavaria
Country
GERMANYAddress
Postfach 2509, Fichtenstrasse 43, Furth, Bavaria, Germany
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).
LENS CERT
The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.
Refusal History
Frequently Asked Questions
What is Uvex Sports Gmbh And Co Kg's FDA import refusal history?
Uvex Sports Gmbh And Co Kg (FEI: 1000260654) has 1 FDA import refusal record(s) in our database, spanning from 10/18/2018 to 10/18/2018.
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. Uvex Sports Gmbh And Co Kg's FEI number is 1000260654.
What types of violations has Uvex Sports Gmbh And Co Kg received?
Uvex Sports Gmbh And Co Kg 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 Uvex Sports Gmbh And Co Kg come from?
All FDA import refusal data for Uvex Sports Gmbh And Co Kg 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.