DIMALASH AND DIMALENS
⚠️ High Risk
FEI: 3041102833 • Dubai, Dubai • UNITED ARAB EMIRATES
FEI Number
3041102833
Location
Dubai, Dubai
Country
UNITED ARAB EMIRATESAddress
Mirza Wasfi Street 10tla Al Ali, Khaldaum Al Somaq Amman Jordan, Dubai, Dubai, United Arab Emirates
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 PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/18/2025 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 237NO PMA | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is DIMALASH AND DIMALENS's FDA import refusal history?
DIMALASH AND DIMALENS (FEI: 3041102833) has 1 FDA import refusal record(s) in our database, spanning from 12/18/2025 to 12/18/2025.
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. DIMALASH AND DIMALENS's FEI number is 3041102833.
What types of violations has DIMALASH AND DIMALENS received?
DIMALASH AND DIMALENS 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 DIMALASH AND DIMALENS come from?
All FDA import refusal data for DIMALASH AND DIMALENS 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.