UNICO EYE
⚠️ High Risk
FEI: 3039099861 • Shenzhen • CHINA
FEI Number
3039099861
Location
Shenzhen
Country
CHINAAddress
901a1 No 6, Kangi City, Shenzhen, , China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
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
Frequently Asked Questions
What is UNICO EYE's FDA import refusal history?
UNICO EYE (FEI: 3039099861) has 2 FDA import refusal record(s) in our database, spanning from 10/16/2025 to 10/16/2025.
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. UNICO EYE's FEI number is 3039099861.
What types of violations has UNICO EYE received?
UNICO EYE 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 UNICO EYE come from?
All FDA import refusal data for UNICO EYE 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.